EXBLIFEP

FDA Approves Exblifep for the Treatment of Complicated Urinary Tract Infections

Allecra Therapeutics (“Allecra”) announced that the U.S. Food and Drug Administration has approved Exblifep as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older. Allecra has also received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act). The GAIN Act, enacted by the U.S. Congress, incentivizes the creation of new anti-infective therapeutics by providing benefits to manufacturers of Qualified Infectious Disease Products (QIDPs).

Exblifep is a combination antibiotic used for complicated urinary tract infections (cUTIs) that contains two antibiotics, cefepime and enmetazobactam. Exblifep is used when the bacteria causing the UTI is resistant to other antibiotics, especially if the resistance is due to Extended Spectrum Beta Lactamases (ESBLs).

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BIKTARVY®

U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy to Treat People with HIV with Suppressed Viral Loads, Pre-Existing Resistance

Gilead Sciences, Inc. has announced the U.S. Food and Drug Administration (FDA) approved a new, expanded indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat people with HIV (PWH) who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance. HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH. The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes.

This label update is supported by Study 4030, which evaluated the efficacy, safety, and tolerability profile of Biktarvy in a broad range of people with HIV-1 with or without pre-existing NRTI resistance, including those with the M184V/I resistance. Biktarvy is now the first and only integrase strand transfer inhibitor (INSTI)-based single-tablet regimen that is FDA approved and U.S. Department of Health and Human Services (DHHS) guideline recommended for PWH who are virally suppressed with M184V/I resistance.

Once someone with HIV has developed resistance to a treatment, it will persist for the rest of their life. Reducing the risk of drug resistance is a key goal in HIV therapy. HIV drug resistance continues to receive clinical and public health attention because it may hinder the ability of HIV medicines to suppress and block replication of the virus over the course of an individual’s life. Resistance may lead to treatment failure in individuals, while also creating the potential for transmission of treatment-resistant HIV within communities.


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SIMLANDI

FDA Approves Simlandi (adalimumab-ryvk), an Interchangeable Biosimilar to Humira

Alvotech and Teva Pharmaceuticals, have announced that the U.S. Food and Drug Administration (FDA) has approved Simlandi (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. In 2023, Humira was one of the highest-grossing pharmaceutical products in the world, with sales in the U.S. of nearly $12.2 billion. Teva is Alvotech’s strategic partner for the exclusive commercialization of Simlandi in the United States.

Simlandi is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA and will qualify for interchangeable exclusivity for the 40mg/0.4ml injection. While both low-concentration and high-concentration strength biosimilars of Humira are marketed in the U.S. today, nearly 88 percent of U.S. prescriptions for adalimumab are for the highconcentration presentation.

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XOLAIR

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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AURLUMYN

FDA Approves Aurlumyn (iloprost) as the First Medication to Treat Severe Frostbite
The U.S. Food and Drug Administration (FDA) approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. The FDA granted the approval of Aurlumyn to Eicos Sciences Inc.

Frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation. Iloprost, the active ingredient in Aurlumyn, is a vasodilator (a drug that opens blood vessels) and prevents blood from clotting.

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CDC May Consider Loosening COVID Isolation Guidance

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

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

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

Onivyde Regimen

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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Scientists Develop Sensor That Tests Saliva for Breast Cancer

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.

EOHILIA

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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Deflazacort

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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