Provention Maps Possible Regulatory Path For Troubled Teplizumab
Biotech Aims To Get Type A Meeting With FDA In Q4
Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.
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Sanofi is taking full control of the recently approved type 1 diabetes prevention therapy Tzield by splashing out $2.9bn to acquire partner Provention.
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At nearly $194,000, the wholesale acquisition cost for Tzield came in above analysts’ $100,000-$115,000 estimates, but payer pushback is not expected as the drug faces no competition.
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Sanofi has deprioritized its presence in type 1 diabetes in recent years but could help turn teplizumab into a game-changer blockbuster product.