FDA & Pharma: What’s A Deadline Among Friends?
3 CommentsBy Ed Silverman // October 17th, 2008 // 4:18 pm
The agency has missed a good many deadlines for reviewing new drugs. And Reuters has been sporting enough to come up with the following list:
- Prasugrel, a blood thinner from Lilly and Daiichi Sankyo. A decision was due September 26 and the application remains pending;
- Promacta, a Glaxo drug for a clotting disorder. The deadline was September 19. and no decision has been made;
- Nplate, a clotting disorder drug from Amgen. A decision was due July 23. The drug was approved August. 22;
- Telavancin, an antibiotic from Theravance. No ruling was made at the deadline of July 21. The drug is now scheduled to go before an FDA advisory panel on November 19;
- Entereg, a drug from Glaxo and Adolor to treat a complication of bowel surgery. The product was approved on May 20, which was 10 days after the May 10 deadline.
- Cimzia, UCB’s treatment for the bowel disorder Crohn’s disease. The deadline was March 30, and the drug was approved April 22;
- Lexiscan, a heart-imaging agent from CV Therapeutics and Astellas Pharma. A decision was due March 14, and it was approved on April 10;
- Kynapid, an atrial fibrillation treatment from Cardiome Pharma and Astellas. A ruling was expected January 19. The companies said in August they had received an FDA “approvable letter” requesting more information;
- Alogliptin, a Takeda diabetes drug. The FDA will miss the October 27 target date.
Anon
Let’s not forget Asenapine. Schering Plough announced that it was filed just after Thanksgiving last year. This means that it was submitted no later than early October last year and more likely several weeks earlier. Thus over a year has passed since it was submitted. Since the review clock is 10 months this means that the letter should have been sent a few months ago.
Schering Plough needs asenapine to make up for all the lost sales from Vytorin not only to replace lost income but its income stream is also needed to fund the drugs in the development pipeline.
SP is not in good situation and no news is NOT good news. Looks like more difficulties for SP and its stock price.
Anon2
And what about Roche’s March 2007 sNDA for Xeloda (for use with Eloxatin in the XELOX regimen), which was last mentioned publicly by Roche in December 2007, only to have disappeared from the news? The PDUFA date should have been January 25, 2008.
Ed Silverman
Hi Anon2,
Thanks for pointing that out. Like any list of this sort, comprehensiveness can be hard to achieve. If anyone else has another drug to add, please do so.
Regards
ed