Drugs

FDA Denies Petition Seeking Wakix Withdrawal

FDA has denied a 4/2023 petition (see earlier story) that called on the agency to withdraw approval for Harmony Biosciences’ Wakix (pitolisant) and take other actions against the drug. Wakix has been indicated to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.

The petition said Scorpion founder and chief investment officer Kir Kahlon conducted a four-month investigation into the drug’s safety and effectiveness and determined that Wakix “poses a grave danger to patients, as evidenced by the inherent and well-documented toxicity of histamine H3 receptor antagonist/inverse agonists as a drug class and by that of pitolisant specifically given its molecular structure, as well as by serious and fatal adverse events that petitioner has identified through a variety of methods….”

In a 6/21 denial letter, FDA says it considered whether any of the information provided in the petition affects the agency’s conclusions about the safety and effectiveness of Wakix. The petition asserted that “pitolisant’s flagrant cardiotoxicity and QT profile” presented serious safety risks to its patient population. The agency letter says a “comprehensive review” of the arguments in the petition “concluded that pitolisant’s labeling adequately addresses risks associated with QT prolongation and arrhythmias.”

Additionally, FDA’s letter disagrees with the petition’s assertion that “notations in CDER’s review for the original NDA regarding sudden deaths, cardiovascular and respiratory adverse reactions, seizures, and convulsions indicate that pitolisant is not safe. Our review of the fatal cases in the premarketing safety database, including the eight the petition classified as sudden deaths, does not support the petition’s assertion about cardiotoxicity for pitolisant. Further, review of other cardiovascular adverse events did not reveal a consistent and clear causal association with pitolisant exposure.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome