Complete response letters

The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.

Novartis, Gilead, Roche and Takeda commit to new partners in a spate of mid-sized collaborations this week. Meanwhile, Applied Therapeutics’ stock tanks 80% after govorestat is denied approval, Intra-Cellular Therapies seeks to expand Caplyta into major depressive disorder and the FDA investigates the safety of bluebird bio’s Skysona.

After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.

The regulator cited deficiencies at a third-party manufacturing facility. Camurus is seeking approval for its extended-release subcutaneous formulation of octreotide, which would allow more convenient once-monthly dosing for patients with acromegaly.

The rejection is related to the timing of the FDA’s reinspection of Zealand’s third-party manufacturer, which previously had deficiencies.

Vanda Pharmaceuticals on Thursday announced that the regulator declined to approve its application, a decision the company says was delayed by more than 185 days and failed to satisfy the requirements of the Federal Drug and Cosmetic Act.

The regulator’s Complete Response Letter flagged problems at a third-party fill/finish site, which Regeneron says it has already addressed. The manufacturing facility is currently awaiting reinspection.

Citing the need for another human factor study and more technical data for the final product, the FDA denied approval of Orexo’s nasal spray rescue medication for opioid overdose.

The FDA’s Complete Response Letter turned down Novo Nordisk’s Biologics License Application for its once-weekly basal insulin icodec injection for diabetes mellitus, with “requests” related to the manufacturing process and the type 1 diabetes indication.

Rocket Pharmaceuticals’ gene therapy Kresladi has been hit with an FDA Complete Response Letter requesting additional chemistry, manufacturing and controls information to complete its review.