Novo Nordisk ($NVO) has received more bad news from the FDA. The agency has delivered a second complete response to the Danish drugmaker for its recombinant Factor XIII therapy, BioCentury reported, citing unresolved findings at the facility where the company manufactures the drug.
The CRL follows a February 2012 denial from U.S. regulators for the hemophilia therapy and marks another setback for Novo with the agency, which handed the company a crushing rejection for its long-acting insulin therapy Tresiba early this year. The Factor XIII product serves a relatively small population of bleeding-disorder patients, but Tresiba is considered one of the crown jewels of the company's leading diabetes franchise.
Novo has struggled to advance its pipeline of treatments for hemophilia too. Last year the company abandoned development of a Factor VIIa therapy after researchers found antidrug antibodies in patients. While Novo works to build a lineup of bleeding-disorder products behind its approved Novoseven, Biogen Idec ($BIIB) has been racing ahead with two long-acting clotting factors that could capture significant shares of the market for hemophilia A and hemophilia B treatments.
Novo develops drugs for chronic diseases and has been facing the FDA's close scrutiny of such treatments in part because patients often take them for life and the tolerance for safety and quality issues at the agency is extremely low.
"There is no doubt that the FDA has this safety-first principle. They have publicly stated that," Mads Krogsgaard Thomsen told me in an interview in June at the American Diabetes Association annual meeting in Chicago. "Which relates to [CDER chief] Janet Woodcock and her various divisions wanting to avoid, you can argue, future drug scandals. Because every time it falls back on the agency, so obviously they are very cautious. Whether they are even more cautious is difficult for me to say."
BioCentury reported that Novo is working to resolve the issues that the FDA brought up in its latest denial for the recombinant Factor XIII therapy.
- check out BioCentury's article
Editor's note: This article has been updated and corrected say Factor XIII rather than Factor VIII.