FDA Approves Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of Advair Diskus

In continuation of my updates on fluticasone propionate & salmeterol

              

Mylan N.V. (NASDAQ: MYL)  announced the U.S. Food and Drug Administration (FDA) approval of Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of Advair Diskus.

Wixela Inhub will launch in the second half of February incorporating the latest safety information required by FDA earlier this month, which prompted an amendment to the label for certain inhaled corticosteroids, including Advair Diskus and any generic versions. Wixela Inhub will be available in the 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths for asthma patients and the 250 mcg/50 mcg strength for COPD patients.

Mylan CEO Heather Bresch commented, "Mylan remains steadfast in its efforts to expand patient access to medicines, and the FDA approval of Wixela Inhub reinforces our commitment to provide patients greater choice and lower-cost alternatives. This milestone represents the culmination of an extensive research and development program and Mylan's more than $700 million of investment. We're proud of our Wixela Inhub team, who worked tirelessly and in close collaboration with the FDA to bring this important medicine to market and add it to our growing global portfolio of more than 700 respiratory products. As one of the leading providers of prescription medicines in the U.S., we continue to execute on our mission and do our part to reduce costs for patients and identify pathways that help increase sustainability for the U.S. healthcare system overall."

Wixela Inhub is indicated for the twice daily treatment of asthma in patients age 4 and older not adequately controlled on long-term asthma control medications or whose disease warrants initiation of treatment with both inhaled corticosteroids and long-acting beta agonists; maintenance treatment of COPD; and the reduction of COPD exacerbations in patients with a history of exacerbations. It is not indicated for the relief of acute bronchospasm.

Mylan President Rajiv Malik added, "We're pleased to offer the first FDA-approved generic of Advair Diskus, one of the leading treatments for asthma and COPD management today. We've long been confident in the science around this product and are proud of the dedication of our scientific teams to bring Wixela Inhub to market. This complex product required a rigorous research and development program spanning over a decade and close collaboration with FDA to define the regulatory pathway. We also are proud to manufacture Wixela Inhub in our own state-of-the-art plant. This approval reinforces our ongoing commitment to increase access to more affordable treatment options for patients."

The research and development program for Wixela Inhub compared all strengths of treatment to Advair Diskus in order to meet the FDA requirements of therapeutic equivalence for a substitutable generic. In the 28-day, randomized, double-blind, placebo-controlled, parallel group study of 1,128 adult asthma patients conducted to evaluate the local (lung) bioequivalence of Wixela Inhub 100 mcg/50 mcg and ADVAIR DISKUS 100 mcg/50 mcg, the two treatments produced equivalent efficacy. Both treatments were safe and well-tolerated with lower numbers of withdrawals due to asthma compared to the placebo group. The study included both naive and current users of Advair Diskus.

"Patients enrolled in clinical trials found Wixela Inhub easy-to-use and highly effective at controlling their asthma in a clinical bioequivalence study. Asthma and respiratory specialists and primary care providers welcome this generic alternative to benefit many patients with asthma and COPD.  We have waited for years for generic inhalers to emerge in respiratory medicine," said Edward Kerwin, MD of Crisor LLC, a division of the Clinical Research Institute located in Medford, Ore. and a Clinical Investigator on the Wixela Inhub clinical program.

Advair Diskus had U.S. sales of $4.2 billion for the 12 months ending November 30, 2018, according to IQVIA.

https://en.wikipedia.org/wiki/Salmeterol

https://www.drugbank.ca/drugs/DB00588

FDA Approves Kaléo’s Auvi-Q (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children

In continuation of my update on epinephrine

Kaléo, a privately-held pharmaceutical company,  announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Auvi-Q (epinephrine injection, USP) 0.1 mg, the first and only epinephrine auto-injector (EAI) specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 pounds (7.5 to 15 kilograms) who are at risk for or have a history of serious allergic reactions.

The sNDA for the Auvi-Q 0.1 mg Auto-injector was granted Priority Review by the FDA, an expedited regulatory pathway reserved for products that may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to available therapies.

Auvi-Q is a compact epinephrine auto-injector with industry-first features, including a voice prompt system that guides a user with step-by-step instructions through the delivery process, and a needle that automatically retracts following administration. The new 0.1 mg-dose epinephrine auto-injector has a shorter needle length and lower dose of epinephrine than current FDA approved 0.15 mg and 0.3 mg epinephrine auto-injectors.

Children are increasingly being treated for anaphylaxis. There was a 129.8 percent increase in emergency room visits for anaphylaxis among children four years old and younger between 2005 and 2014.[i] According to a study published in Allergy, Asthma & Clinical Immunology, 43 percent of children weighing 16.5 pounds (7.5 kilograms) to 33 pounds (15 kilograms) treated with a 0.15 mg EAI having a standard 12.7 mm needle length are at risk of having the needle strike the bone, therefore potentially impacting the administration of epinephrine during a life-threatening emergency.[ii] The needle length in Auvi-Q 0.1 mg was specifically designed for use with infants and small children to help mitigate this safety concern.

“Today’s decision by the FDA to approve the Auvi-Q 0.1 mg Auto-injector is exciting for all of us in the life-threatening allergy community who have been working for many years to fulfill this unmet medical need,” said Spencer Williamson, President and CEO of kaléo. “As a company that focuses on patients first, and providing potentially life-saving treatments, we are particularly glad we will be able to help caregivers by providing an EAI that was specifically designed with an appropriate dose and needle length for infants and children (16.5 to 33 pounds) in order to maximize the potential for a safe administration of epinephrine.”

“The approval of Auvi-Q 0.1 mg will help achieve our goal of working to fulfill unmet medical needs,” said Eric S. Edwards, MD, PhD, Vice President of Innovation and Research & Development at kaléo. “We developed the Auvi-Q 0.1 mg EAI to deliver a dose of epinephrine appropriate to infants and small children weighing 16.5 – 33 pounds, with a shorter needle length to help mitigate the risk of striking bone which could potentially cause injury or interfere with the delivery of epinephrine.”

Only Auvi-Q 0.1 mg has a dose and needle length designed specifically for treating anaphylaxis in infants and small children weighing 16.5 – 33 pounds. Auvi-Q 0.1 mg includes the innovative AUVI-Q electronic voice instruction system as well as visual cues to help guide users step-by-step through the administration.

“The approval of an epinephrine auto-injector specifically designed for infants and small children is timely, especially given the recent changes to guidelines recommending that certain high-risk infants, as young as four to six months old, be introduced to peanut-containing foods,” said Eleanor Garrow-Holding[1], President and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT). “We are pleased that the pediatric allergy healthcare community and parents of infants and small children with life-threatening allergies will have the ability to obtain an FDA-approved epinephrine auto-injector in the event of an allergic emergency. We look forward to the availability of Auvi-Q 0.1 mg.”

“Until now, healthcare practitioners and caregivers to infants and small children have not had an epinephrine auto-injector with an appropriate dose of epinephrine available to them, potentially causing some delay in the administration of epinephrine in a life-threatening allergic emergency,” said Dr. Vivian Hernandez-Trujillo[1], a pediatric allergist, and fellow of the American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; and American Academy of Pediatrics specializing in the management of life-threatening allergies and anaphylaxis. “Having an epinephrine auto-injector with a needle length and dose specifically designed for infants and small children should help alleviate concerns around hitting the bone or injecting too much epinephrine.”

Identical twin brothers, Evan and Eric Edwards, the inventors of Auvi-Q, know what it is like to live with life-threatening allergies, both as patients and parents of food-allergic children. Their goal was to develop an epinephrine auto-injector that contained innovative features, such as a voice instruction system that helps guide patients and caregivers step-by-step through the injection process. Evan and Eric Edwards believe and trust in Auvi-Q, not only for themselves, but also for their children and other families who may have to depend on it to administer epinephrine during an allergic emergency.

FDA Approves Kaléo’s Auvi-Q (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children

FDA Approves Ascor (Ascorbic Acid Injection, USP) for the Treatment of Scurvy

McGuff Pharmaceuticals, Inc., a wholly owned subsidiary of McGuffCompany, Inc. announces the United States Food and Drug Administration’s New Drug Approval (NDA) of Ascor (Ascorbic Acid Injection, USP). Ascor is provided in a 50 mL vial labeled as a Pharmacy Bulk Package with a strength of 500mg/mL.

Ascor is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated.

Ascor is the first single moiety ascorbic acid drug approved for the US market and is the result of a multi-year development effort.

Ronald McGuff, CEO said "The FDA approval of Ascor Ascorbic Acid
Injection USP will allow McGuff Pharmaceuticals, Inc. to deliver this
medically necessary drug to US hospitals and pharmacies to improve
patient health. In addition, McGuff Pharmaceuticals, Inc. currently
holds Ascorbic Acid Injection USP approvals in multiple other
countries."