Monthly Archives: July 2023

FDA Approves RiVive™ (naloxone hydrochloride 3 mg) Over-the-Counter Nasal Spray for the Emergency Treatment of Opioid Overdose

Harm Reduction Therapeutics (HRT), Inc., has announced that the FDA has approved OTC RiVive™ (naloxone HCl nasal spray 3 mg) for the emergency treatment of opioid overdose. It is not a controlled substance, according to the US Drug Enforcement Administration (DEA).

This critical milestone will help prevent opioid overdose deaths by making free or low-cost, over the counter (OTC) naloxone nasal spray available to everyone in the United States.

RiVive nasal spray works by rapidly reversing the opioid’s effects as it is an opioid antagonist. RiVive competes for the opiate receptors in the brain and other areas of the body to help reverse the dangerous effects of the opioid so that the patient’s breathing improves, they become more awake, and their blood pressure normalizes.

It is expected that RiVive nasal spray will be available in early 2024

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FDA Approves Balfaxar® for Reversal of Acquired Coagulation Factory Deficiency Induced by Vitamin K Antagonist in Adults

Octapharma USA has announced that Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) has received U.S. Food and Drug Administration approval for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.

More than 2.4 million people in the United States use warfarin to keep their blood from clotting after a heart attack, stroke, or other serious thromboembolic complication. Balfaxar helps to restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy.

Balfaxar is a non-activated four factor prothrombin complex concentrate (4F-PCC) containing vitamin K dependent factors: Factor II (prothrombin), Factor VII, Factor IX, and Factor X, as well as antithrombotic Proteins C and S.

The most common adverse reactions in those who received the candidate 4F-PCC (≥3%) being procedural pain, wound complications, asthenia, anemia, dysuria, procedural vomiting, and catheter site-related reaction.

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Xdemvy™ Eye Drop (lotilaner 0.25% ophthalmic solution) approved by FDA July 25, 2023 – Xdemvy™, an anti-parasitic eye drop solution that may be used to treat Demodex blepharitis in adults 18 years of age and older, has been approved by the FDA. Xdemvy is the first and only approved therapeutic for Demodex blepharitis, a highly prevalent eyelid disease that impacts approximately 25 million eye care patients in the U.S.

Demodex blepharitis is a disease caused by an infestation of the eyelashes and eyelash follicles by Demodex mites, the most common ectoparasite found in humans. It is reasonably common, accounting for 45% of blepharitis cases overall, and 84% in people aged 60 and older. Symptoms of Demodex blepharitis include eyelid margin inflammation, redness, and ocular irritation, and it commonly occurs
with rosacea or conditions such as diabetes.

Xdemvy works by inhibiting the gamma-aminobutyric acid (GABA)-gated chloride channels in the Demodex mites to cause paralysis in the mite and its death, and relief of eyelid redness and crusting. Lotilaner does not inhibit GABA-mediated chloride channels in humans at 1100 times the recommended human dose.

The most common side effects of Xdemvy in clinical trials were stinging and burning in 10% of patients.  Other side effects in less than 2% of patients were chalazion/hordeolum and punctate keratitis.  Xdemvy is expected to be available by prescription by the end of August 2023.

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FDA Approves Verrica Phamaceuticals’ Ycanth™ for Treatment of Molluscum Contagiosum

Verrica Pharmaceuticals Inc., has announced that the U.S. Food and Drug Administration has approved Ycanth™ (cantharidin) topical solution for the treatment of molluscum contagiosum adult and pediatric patients 2 years of age and older.

Molluscum contagiosum is a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum contagiosum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels, or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum contagiosum can last for an average of 13 months, and in some cases, up to several years.

Ycanth is a proprietary drug-device combination product containing a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator, allowing for precise topical dosing and targeted administration. Ycanth must be administered by a healthcare professional trained in its administration. Verrica plans to make Ycanth ™ available by September 2023.The approval is based on positive results from two identical Phase 3 randomized, double-blind, multicenter clinical trials (CAMP-1 and CAMP-2) that evaluated the safety and efficacy of VP-102 (Ycanth) compared to a placebo in patients two years of age and older diagnosed with molluscum contagiosum.

There were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate.

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Emergent BioSolutions Receives U.S. FDA Approval of Cyfendus™

Emergent BioSolutions Inc. has announced that the U.S. Food and Drug Administration has approved Cyfendus™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.

Cyfendus is a component of the U.S. government’s preparedness efforts, working with the U.S Department of Health against anthrax since 2019. It has been demonstrated that by using an additional adjuvant, two doses administered over 14 days elicit protective levels of immune response, it can be especially important in response to a large-scale public health emergency involving anthrax.

The FDA approval of Cyfendus is based on data from a series of studies supported by the U.S. government and conducted by Emergent.

The most common adverse reactions reported were tenderness, pain, warmth, itching, swelling, redness, bruising, arm motion limitations, muscle aches, tiredness, headache, and fever. Cyfendus can cause fetal harm when administered to a pregnant individual.

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Use of Vanflyta® Approved by FDA for Treating Adult Patients With AML, Acute Myeloid Leukemia

Daiichi Sankyo has announced that Vanflyta® (quizartinib) has been approved by the U.S. Food and Drug Administration. Vanflyta is an oral kinase inhibitor that may be used to treat adults with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive, in combination with standard treatments (cytarabine and anthracycline induction and cytarabine consolidation and maintenance). Vanflyta is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with Vanflyta in this setting has not been demonstrated.

Up to 37% of newly diagnosed patients with AML have a FLT3 gene mutation and approximately 80% of these are FLT3-ITD mutations, which drive cancer growth and contribute to increased risk of relapse and shorter overall survival. The five-year survival rate for patients with FLT3-ITD AML has been reported at approximately 20%.

Do not take Vanflyta if you have very low potassium, very low magnesium, long QT syndrome, or a history of ventricular arrhythmias or torsades de pointes. Vanflyta may cause embryo-fetal toxicity. Females who can become pregnant should use effective birth control during treatment with Vanflyta and for 7 months after the last dose. Males with female partners who can become pregnant should use effective birth control during treatment and for 4 months after the last dose.

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The Food and Drug Administration granted traditional (full) approval to Leqembi, the Alzheimer’s treatment jointly developed by Biogen and Eisai, on July 6th.

In early June, external advisors to the FDA unanimously recommended Leqembi for full approval. The widely expected approval comes six months to the day after the FDA gave the drug a greenlight through its accelerated pathway program.

Leqembi’s initial launch has rolled out in strong fashion, complete with first recorded sales, prescription written and patient infusion over the past few months. The drug is on track to be a blockbuster, with one analysis projecting nearly $13 billion in global sales by 2028. This would be 17-times the sales total of Aricept, the second-longest approved Alzheimer’s drug.

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FDA Approves Beyfortus™ as Prevention of RSV in Newborns and Children Up To 24 Months Old

The U.S. Food and Drug Administration has approved Sanofi and AstraZeneca’s Beyfortus™ (nirsevimab alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Premature infants and those with chronic lung disease of prematurity or significant congenital heart disease are at highest risk for severe RSV disease. RSV is a virus that causes acute respiratory infection in individuals of all age groups. While most infants and young children experience mild, cold-like symptoms, some infants, especially with their first infection, develop lower respiratory tract disease such as pneumonia and bronchiolitis (swelling of the small airway passages in the lungs), that often leads to an emergency department or physician office visit.

In most parts of the U.S., RSV circulation is seasonal, typically starting during the fall and peaking in the winter; it is transmitted from person to person through close contact with someone who is infected. Approximately 1% to 3% of children under 12 months of age in the United States are hospitalized each year due to RSV, according to the American Academy of Pediatrics.

Sanofi and AstraZeneca plan to make Beyfortus available in the U.S. ahead of the upcoming 2023- 2024 RSV season. Each year, an estimated 590,000 RSV disease cases in infants under one require medical care, including physician office, urgent care, emergency room visits and hospitalizations.

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The U.S. Food and Drug Administration has approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for use in the U.S. without a prescription. The FDA granted the approval to Laboratoire HRA Pharma, recently acquired by Perrigo Company plc.

Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.

The contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973. HRA Pharma applied to switch norgestrel from a prescription to an over-the-counter product. For approval of a product for use in the nonprescription setting, the FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional.

Opill starts working 2 days after you start taking it, but you must take it every day at the same time each day for it to continue to be effective. You must take Opill continuously every day without a break between blister packs.

Opill was FDA-approved for OTC (over-the-counter) use on July 13, 2023, and should be available in stores starting in January or February 2024.

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By Denise Mann HealthDay Reporter

The drugs Wegovy and Ozempic are all the rage for weight loss these days, and now a new study shows these injections may be game-changers for obese teenagers, too.

This trial, funded by drug maker Novo Nordisk, found that nearly half of all adolescents on semaglutide (Wegovy/Ozempic) were able to achieve a healthy weight in about 17 months.

Semaglutide is a GLP-1 receptor agonist, which slows digestion, decreases hunger, reduces how much people eat and prompts weight loss. The U.S. Food and Drug Administration has approved Wegovy for treating obesity in kids and adults aged 12 years and older, while Ozempic has been approved at a lower dose to treat type 2 diabetes.

“Semaglutide appears to be highly effective in helping teens reduce their body mass index [BMI] to a level below the clinical cutoff for obesity,” said study author Aaron Kelly, co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota Medical School, in Minneapolis. “Pharmacotherapy should be offered to all adolescents with obesity who are medically eligible.”

For the study, teens with high BMIs received either 2.4-mg of semaglutide weekly (the maximum dose) or a dummy (placebo) injection for 17 months. Everyone in the study was encouraged to exercise for 60 minutes a day and got advice about healthy eating.

Fully 45% of teenagers who took once-weekly semaglutide lost enough weight to drop below the clinical cutoff for obesity, meaning they moved to the normal weight or overweight category. By contrast, just 12% of the teens in the placebo group achieved that status.

These improvements were seen across gender and age, as well as in teens with severe obesity. The side effects were in line with what has been seen in adults, Kelly said, with the most common being nausea and vomiting.

The study was published online recently in the journal Obesity. Dr. Susma Vaidya is a pediatrician at Children’s National Hospital’s Improving Diet, Energy, and Activity for Life Clinic, in Washington, D.C. “We got really excited after the initial studies looking at semaglutide in teenagers, and this follow-up shows that almost 45% of teens taking semaglutide were able to achieve a normal or overweight BMI,” said Vaidya, who was not involved in the new study. “This is great evidence of the importance and value of [weight-loss medication] in teens,” she added.

The study authors did find that kids who had an improvement of two or more BMI categories tended to be younger and had a lower weight, BMI and waist circumference than those who showed less improvement. “This tells me that we need to think about using these medications earlier,” Vaidya said.

The American Academy of Pediatrics backs this up in its latest guidelines on childhood obesity treatment. They state that children with obesity should be evaluated and treated early and aggressively, including with medications. It’s not just the weight loss, Vaidya said. “These kids also become healthier.”

The decision to take weight loss medication involves a careful discussion with your teen’s doctor. Factors that play a role include the presence of any obesity-related conditions such as diabetes or high blood pressure.

“Candidates tend to have more severe obesity and have been working on their weight and are having a hard time keeping it off,” said Vaidya, who often prescribes Ozempic, not Wegovy, to teens as many insurers will not cover obesity medication. “I am more likely to get Ozempic covered,” she noted. What happens when teens stop taking Ozempic?

“The expectation is when you stop taking the medication, you will gain the weight back,” Vaidya said. Exactly how soon this will happen or how much weight will return is not known as many factors affect weight regain. Despite the promise of these drugs, there is no magic bullet for weight loss, she cautioned. “The foundation is lifestyle changes including eating a healthy diet and getting regular exercise,” she stressed.

Sources
• Aaron Kelly, PhD, co-director, Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis
• Susma Vaidya, MD, MPH, pediatrician, Improving Diet, Energy and Activity for Life (IDEAL) Clinic, Children’s National Hospital, Washington, D.C.
• Obesity, July 9, 2023, online