Bavarian Nordic agrees on Imvamune path with FDA
This article was originally published in Pharmaceutical Approvals Monthly
Bavarian Nordic's third generation smallpox vaccine Imvamune could be the first vaccine to be licensed using FDA's animal efficacy rule, which allows approval based on animal efficacy and human safety data in cases where human exposure to a pathogen would be unethical. At an end-of-Phase II meeting with regulators, "the animal efficacy models and Phase III protocol have essentially been agreed with the agency - outlining a clear path for licensure of Imvamune," the firm announced March 3. However, once the Phase III protocols have been cleared with FDA, the agency will convene the Vaccines and Related Biological Products Advisory Committee to review the license strategy. That will push initiation of the Phase III trials to late 2010, with BLA submission in 2013. FDA solicited development of third-generation smallpox vaccines based on attenuated vaccine strains (Imvamune uses modified vaccinia Ankara) as potentially safer alternatives to second-generation vaccines, which have been associated with adverse events. Bavarian Nordic has been working on its MVA smallpox vaccine since 1999, funded partially under a Bioshield grant, and has a contract to supply Imvamune to the strategic national stockpile
You may also be interested in...
Former senior advisor to President Trump warns that failure to reform drug pricing practices has seriously handicapped prospects for reimbursing cell and gene therapy under existing US payer programs.
A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.
Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals.