FDA Approves new indication for Xolair

The U.S. Food and Drug Administration (FDA) approved a new indication for Genentech/Novartis’ Xolair (omalizumab), an anti-immunoglobulin E (IgE) antibody. Xolair is now indicated for IgE-mediated food allergy in adult and pediatric patients 1 year of age and older for the reduction of allergic reactions (Type I). This includes anaphylaxis, that may occur with accidental exposure to one or more foods. Xolair is intended to be used in conjunction with food allergen avoidance.

Xolair was first approved in 2003 for moderate to severe persistent allergic asthma and has since been approved for perennial aeroallergen allergies, to treat chronic idiopathic urticaria, and as an add-on maintenance treatment for nasal polyps in adults with inadequate response to nasal corticosteroids. Xolair does not treat acute allergic food reactions and does not replace the use of epinephrine for such reactions. Patients taking Xolair for food allergies may need to continue to carry epinephrine for treating emergency allergic reactions.

Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure. Aimmune Therapeutics’ Palforzia (peanut [Arachis hypogaea] allergen powder-dnfp) is an oral immunotherapy product approved in patients 4–17 years of age for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut, but its use is restricted to peanut allergy. There are other agents in development for food allergies, including some for multiple food allergies.

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By Robin Foster HealthDay Reporter, Medically reviewed by Carmen Pope, BPharm.

New, proposed guidance being weighed by the U.S. Centers for Disease Control and
Prevention recommends that Americans who test positive for COVID-19 no longer need to routinely stay home for five days.

This is the first time the agency has even considered loosening its COVID isolation guidelines since 2021, and the thinking behind the possible shift is to align them with similar guidance on the flu and RSV, according to four agency officials and an expert familiar with the discussions, the Washington Post reported Tuesday.

However, the CDC later said in a statement that it had “no updates to COVID guidelines to announce at this time,” adding that it would “continue to make decisions based on the best evidence and science to keep communities healthy and safe,” NBC News reported.

No matter what the CDC decides to do, most Americans have now developed a level of immunity to the virus because of prior infection and/or vaccination, and that calls for a more sensible approach.

“Public health has to be realistic,” Michael Osterholm, an infectious disease expert at the University of Minnesota, told the Post. “In making recommendations to the public today, we have to try to get the most out of what people are willing to do. You can be absolutely right in the science and yet accomplish nothing because no one will listen to you.”

In the proposed guidance, the CDC is weighing plans to recommend that people who test positive for COVID use symptoms as their guide in deciding whether to isolate for five days, the Post reported.

Infected people would no longer need to stay home if they have been fever-free for at least 24 hours without the aid of medication and their symptoms are mild and improving, three agency officials who spoke on the condition of anonymity told the Post.

The CDC’s potential shift follows similar actions already taken by Oregon and California.

Still, easing COVID isolation guidance when the science around the virus’ infectiousness hasn’t changed could anger vulnerable groups, CDC officials and experts told the Post.

Loosening the guidelines “sweeps this serious illness under the rug,” Dr. Lara Jirmanus, a clinical instructor
at Harvard Medical School and member of the People’s CDC, a coalition of health care workers, scientists
and advocates focused on reducing the harmful effects of COVID-19, told the Post.

Public health officials should treat COVID differently from other respiratory viruses because it’s deadlier than the flu and poses a risk for lingering symptoms known as long COVID, she said. Nearly 7% of Americans report having lingering COVID symptoms such as fatigue, trouble breathing, brain fog and joint pain, CDC data show.

The proposed recommendations would not apply to hospitals and other health-care settings with more vulnerable populations, CDC officials told the Post.

Lower rates of COVID hospitalizations were among the reasons California shortened its five-day isolation recommendation last month, urging people to stay home until they are fever-free for 24 hours and their symptoms are mild and improving. Oregon made a similar move last May.

It’s not clear whether the updated CDC guidance will continue to recommend masking for 10 days if infected, the Post reported.

Doctors say the best way for sick people to protect their communities is to mask or avoid trips outside the home if infected.

“You see a lot of people with symptoms — you don’t know if they have COVID or influenza or RSV — but in all three of those cases, they probably shouldn’t be at Target, coughing and looking sick,” Dr. Eli Perencevich, an internal medicine professor at the University of Iowa, told the Post.

Sources:
• Washington Post
• NBC News

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This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.

Ipsen’s Onivyde Regimen, a Potential New Standard-of-Care First-Line Therapy in Metastatic Pancreatic Adenocarcinoma (mPDAC), Approved by the FDA

Ipsen has announced that the U.S. Food and Drug Administration has approved the supplemental new drug application for Onivyde (irinotecan liposome injection) plus oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC).

This is the second approval for an Onivyde regimen in mPDAC, succeeding the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.

Onivyde is a cancer medicine that blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and eventually die.

Pancreatic adenocarcinoma (PDAC) is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally. Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV). Characterized as a complex cancer due to rapid tumor progression, limited genetic targets and multiple resistance mechanisms, mPDAC has a poor prognosis with fewer than 20% of people surviving longer than one year. Overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.

The Napoli 3 study of the Onivyde (Nalirifox) regimen provided a statistically significant improvement in median overall survival of 11.1 months compared to 9.2 months in nab-paclitaxel and gemcitabine treatments.

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By Dennis Thompson, HealthDay Reporter, Medically reviewed by Carmen Pope, BPharm.

Mammograms are a lifesaving misery for middle-aged women, but a new tool could make getting a breast cancer screening as easy as spitting. Literally. A new hand-held biosensor can detect breast cancer biomarkers from a tiny sample of saliva, researchers report Feb. 13 in the Journal of Vacuum Science & Technology B.

“Our device is an excellent choice because it is portable – about the size of your hand – and reusable,” said lead researcher Hsaio-Hsuan Wan, a doctoral student at the University of Florida. “The testing time is under five seconds per sample, which makes it highly efficient.”

The device uses paper test strips treated with specific antibodies that respond to targeted cancer biomarkers, the researchers explained.

When a saliva sample is placed on the strip, pulses of electricity are sent to contact points on the device.

These pulses cause the biomarkers to bind to the antibodies, which alters the electrode’s output signal enough to provide readings regarding cancer risk.

By comparison, mammograms, ultrasounds, and MRI scans are all costly and require big pieces of equipment and low-dose radiation exposure, Wan said.

“In many places, especially in developing countries, advanced technologies like MRI for breast cancer testing may not be readily available,” she added in a university news release.

“Our technology is more cost-effective, with the test strip costing just a few cents and the reusable circuit board priced at $5,” Wan added. “We are excited about the potential to make a significant impact in areas where people might not have had the resources for breast cancer screening tests before.”

The device can provide accurate test results with just a drop of saliva, even if the concentration of the cancer biomarker is a minuscule one-quadrillionth of a gram per milliliter.

One of the biomarkers involves human epidermal growth factor receptor 2 (HER2), a protein that drives 15% to 20% of invasive breast cancers. Another is CA 15-3, an antigen released into the bloodstream by breast cancer.

Results showed the device could distinguish between healthy breast tissue, early breast cancer and advanced breast cancer, using those two biomarkers. Researchers tested the device in 21 human saliva samples. “The highlight for me was when I saw readings that clearly distinguished between healthy individuals and those with cancer,” Wan said. “We dedicated a lot of time and effort to perfecting the strip, board, and other components. Ultimately, we’ve created a technique that has the potential to help people all around the world.”

Sources:

• Journal of Vacuum Science & Technology B, news release, Feb. 13, 2024

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

FDA Approves Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis

Takeda has announced that the U.S. Food and Drug Administration has approved Eohilia (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). It will be available in 2 mg/10 mL convenient, single-dose stick packs by the end of February.

Eohilia is a corticosteroid indicated for 12 weeks of treatment in patients and was developed specifically for EoE. Eohilia’s novel formulation of budesonide confers thixotropic properties, thus flowing more freely when shaken and returning to a more viscous state when swallowed.

EoE is a chronic, immune-mediated, inflammatory disease localized in the esophagus. Although the exact cause is unknown, it is believed to be triggered by a variety of stimuli including certain foods and environmental allergens. The chronic inflammation of EoE can lead to a range of symptoms, which can vary by person and age, and include difficulty swallowing, vomiting and pain.

Identifying EoE can be complex and delayed diagnosis is common among patients. If left untreated, the inflammation of EoE can worsen and narrow the esophagus, which can lead to food impaction (when food becomes stuck in the esophagus).

Eohilia has not been shown to be safe and effective for the treatment of EoE for Longer than 12 weeks.

Warnings and Precautions:
• Hypercorticism and Adrenal Axis Suppression
• Immunosuppression and Increased Risk of Infection
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Brand name: Emflaza
Dosage forms: oral suspension (22.75 mg/mL), oral tablet (18 mg; 30 mg; 36 mg; 6 mg)
Drug class: Glucocorticoids

Deflazacort is a steroid that is used to treat Duchenne muscular dystrophy in adults and children at least 2 years old.

Deflazacort is not a cure for muscular dystrophy, but deflazacort may improve muscle strength and slow the progression of disability.

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Brand names: BromSite, Prolensa, Xibrom, Bromday
Dosage form: ophthalmic solution (0.07%; 0.075%; 0.09%)
Drug class: Ophthalmic anti-inflammatory agents

Bromfenac ophthalmic (for the eyes) is used to treat swelling and pain caused by cataract surgery.
Bromfenac is a non-steroidal anti-inflammatory drug (NSAID).

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Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi® (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During Manufacturing

Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of Zenzedi® CII (dextroamphetamine sulfate tablets, USP) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi® 30 mg tablets and found tablets of Carbinoxamine Maleate, an antihistamine drug. Upon learning of the incident, the manufacturer opened a product complaint and an investigation followed.

Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury. Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder. For patients with Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy (sleep disorder) there is a reasonable probability that accidents or injuries that occur due to the sedating effects of carbinoxamine, could lead to ongoing disability or death in severe cases, particularly if individuals who use it (unaware that they have not received Zenzedi®) engage in activities requiring significant focus and alertness (e.g., driving, operating heavy machinery).

To date, Azurity has not received any reports of serious adverse events related to this recall.

Zenzedi® is a prescription medicine for the treatment of Narcolepsy. Zenzedi® is also indicated as a treatment for attention deficit hyperactivity disorder (ADHD). Zenzedi® is marketed under Arbor Pharmaceuticals, LLC brand. Arbor Pharmaceuticals, LLC is a subsidiary of Azurity Pharmaceuticals, Inc. For additional Zenzedi® safety information, please visit www.azurity.com.

Zenzedi® 30 mg tablets can be identified by light yellow hexagonal tablet debossed with “30” on one side and “MIA” on the other side and distributed in a white bottle with black writing and “30 mg” highlighted yellow. Whereas the description of the suspect tablets (Carbinoxamine Maleate Tablets USP, 4 mg), which was provided by the reporting pharmacist, was white round tablets with imprints of “GL” on one side and “211” on the other side. Product was distributed nationwide through pharmacies.

Azurity Pharmaceuticals, Inc. sent recall notification letters via overnight delivery to wholesale distributors on January 4, 2024, and arranged for the return of all recalled products at that wholesaler level. Consumers that have product which is being recalled should stop using and return to place of purchase. Azurity is working with wholesalers and retailers to arrange for the return and replacement of recalled product. Azurity has enlisted the services of Inmar Intelligence to facilitate the recall. Inmar is located at 3845 Grand Lakes Way, Grand Prairie, TX 75050. All returns from wholesalers and retailers must go to Inmar at this address.

For more information regarding this recall, please reference the following telephone numbers:

• For information regarding the recall process, call Inmar Intelligence at 877-804-2069 (Monday through Friday, 9AM-5PM EST).
• For medical or technical product information or to report a technical product complaint or adverse event please call 800-461-7449 (Monday through Friday, 9AM-5PM EST).

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. An adverse event may also be reported to Azurity via email at aereports@azurity.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Merck announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant, an investigational, non narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.

In the CRL, the FDA concluded that Merck’s application did not meet substantial evidence of effectiveness for treating RCC and UCC. The CRL was not related to the safety of gefapixant. Merck is reviewing the FDA’s feedback to determine next steps.

Chronic cough is defined as a cough lasting longer than 8 weeks. In adults with RCC, the cough persists despite appropriate treatment of underlying conditions such as asthma or gastroesophageal reflux disease, and UCC is a cough where the underlying cause cannot be identified despite a thorough evaluation.

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