Five advisory committee meetings on FDA’s October docket

FDA has five advisory committees on its October calendar, two of which will be held this week.

On Thursday, FDA’s Cardiovascular and Renal Drugs Advisory Committee will review an NDA for elamipretide hydrochloride injection from Stealth BioTherapeutics Corp. to treat Barth syndrome. No therapies are approved for the ultra-rare metabolic disorder. The embattled therapy’s journey through FDA has spanned 10 years and four different review divisions. Patients and their advocates will be pushing for regulatory flexibility, even as the posture in FDA’s briefing document is negative. The therapy’s PDUFA date is Jan. 29.  ...