Reata Pharmaceuticals Inc.’s hopes, as well as those of many people living with Alport syndrome, were dashed Dec. 8 when the FDA’s 13-member Cardiovascular and Renal Drugs Advisory Committee voted unanimously that the available evidence doesn’t show that the benefits of bardoxolone methyl outweighed its risks in treating the rare genetic condition.
The release of the FDA’s briefing document for a Dec. 8 meeting of its Cardiovascular and Renal Drugs Advisory Committee triggered heavy trading and a 38% drop in value in Reata Pharmaceuticals Inc., of Plano, Texas.
A divided FDA advisory committee voted 13-10 Nov. 30 that the known and potential benefits of the Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s antiviral drug, molnupiravir, outweighs its known and potential risks. If granted an emergency use authorization (EUA), molnupiravir would become the first take-at-home oral drug in the U.S. to keep mild and moderate COVID-19 infections from becoming severe in high-risk adults.
It’s decision time for oral drugs that could help the world return to normal even in the midst of the COVID-19 pandemic. The U.K. already has granted emergency authorization to Merck & Co. Inc. and Ridgeback Biotherapeutics Inc.’s antiviral, Lagevrio (molnupiravir), and the EMA is expected to complete its evaluation of the oral drug within the next few weeks. In the U.S., the FDA could announce its decision on Lagevrio shortly after its Antimicrobial Drugs Advisory Committee weighs in Nov. 30 on emergency use authorization.
Compelling testimony from parents who saw life-altering changes in their children who participated in Levo Therapeutics Inc.’s intranasal carbetocin clinical trial wasn’t enough to counter what the FDA’s Psychopharmacologic Drugs Advisory Committee saw as a lack of “substantial evidence” to support the drug’s effectiveness in treating hyperphagia associated with Prader-Willi syndrome (PWS).
The FDA has one question for its Psychopharmacologic Drugs Advisory Committee when it meets Nov. 4: Has Levo Therapeutics Inc. provided substantial evidence that the company’s carbetocin nasal spray is effective in treating hyperphagia associated with Prader-Willi syndrome?
In a move that had been expected, the CDC’s Advisory Committee on Immunization Practices unanimously recommended the Pfizer Inc.-Biontech SE COVID-19 vaccine as safe and beneficial for children ages 5 through 11. The recommendation, coming from a 14-0 vote, is the committee’s way of reassuring the American public that the vaccine is safe, according to committee member Beth Bell, clinical professor in the School of Public Health at the University of Washington in Seattle.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-0, with one abstention, that the benefits of Pfizer Inc.-Biontech SE pediatric formulation of its two-dose COVID-19 vaccine outweigh its risks for children ages 5 through 11. Many of those votes came with caveats, as the VRBPAC members struggled with the unknowns of the vaccine and the fear that schools would mandate its use, even though it would still be considered experimental if the FDA grants it an emergency use authorization.
DUBLIN – Oncopeptides AB has withdrawn its troubled multiple myeloma
drug Pepaxto (melphalan flufenamide) from the U.S. market, less than eight months after receiving an accelerated approval from the FDA. The move comes less than a week before the FDA’s Oncologic Drugs Advisory Committee was due to consider the drug’s safety profile because of data anomalies that surfaced over the summer.
The FDA’s Vaccines and Related Biological Products Advisory Committee unanimously agreed to recommend a booster dose of Janssen Biotech Inc.’s COVID-19 vaccine for those age 18 years and older at least two months following the first dose. In the end, the vote swung on numbers from Janssen showing a booster significantly improved efficacy among study participants. Janssen’s data leaped to 94% protection after a booster dose, up from 70% efficacy following the first dose. That higher efficacy rate nearly matches that of the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE.
