Biogen won’t explain why FDA slapped down their bid for new Tysabri formulation
When it submitted a supplemental Biologic License Application to the FDA, Biogen hoped they could offer patients with multiple sclerosis an easier way of receiving and administering their therapy Tysabri. But Thursday, it received a CRL denying the approval of its filing, and it isn’t offering any explanation behind it.
The company turned down a request for further explanation from Endpoints News Friday.
“This response from the FDA does not affect the intravenous administration of TYSABRI, a well-established high-efficacy treatment with a well-characterized safety profile, which over the last 15 years has treated more than 200,000 people worldwide with relapsing MS,” CMO Maha Radhakrishnan said in a statement.
Biogen hopes to offer its drug through a subcutaneous route of administration. Injections to treat MS were approved in Europe earlier this month, though the drug was originally approved in Europe back in 2006. The injections are dosed at 300 mg every four weeks by a healthcare provider, with the goal of treating patients in a clinical setting beyond infusion centers.
Right now, it takes several hours to have an infusion in a hospital clinic. With subcutaneous injection, the timeframe will be shorter than an infusion, and can be administered closer to a patient’s home, like a hospital or health center.
Biogen plans to pursue regulatory filings for Tysabri in additional countries, the company said in its release, and it has been approved in 80 different countries. The drug has proven to reduce the formation of new brain lesions and cut relapses.
Biogen’s hopes of expanding the Tysabri franchise flopped in 2018, when plans to break it into ischemic stroke failed in a Phase IIB trial. The elimination of the program heightened pressure for Biogen to find success for the drug, which had been in trials to treat Alzheimer’s disease.
The company agreed to a $22 million settlement with the Department of Justice after claims that it violated the False Claims Act by using foundations to pay Medicare copays for patients taking 2 of its MS drugs: Tysabri and Avonex. The DOJ said that doing so violated the Anti-Kickback Statute, intended to limit price hikes.