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Nine months after Zogenix had obtained a $ ZGNX stock move by touting the advanced-stage data of a new drug designed to prevent seizures due to Dravet's syndrome, the FDA made its commercialization application with a d & # 39; Failure for inadequate and incomplete work. Officially, this is called a file denial, which is always embarrassing.
Stephen Farr
For Zogenix, it's not the end of the world, but the agency is not happy that biotechnology has submitted an incorrect version of a data set with the NDA and blames the company for "some non-clinical studies have not been submitted. allow evaluation of chronic administration of fenfluramine. "
Investors did not like at all. Biotech, with a market capitalization of $ 2.2 billion, has seen its stock plummet in the news, plunging 32% after the bell.
However, the EMA has not encountered any problems with its application so far, having accepted it with an expected decision for the first quarter of 2020. Stifle's Paul Matteis is baffled by the whole.
We find the RTF letter for Fintepla disconcerting, a little weird and valid enough to push Fintepla's earnings back to the US until 2021 (with a slightly reduced likelihood adjustment), assuming a conservatively significant delay. That being said, the FDA's request for preclinical toxicology is legitimately confusing: remember, Zogenix has treated more than 200 patients treated with Dravet for one year and is currently conducting a Fintepla LGS trial including an OLE; you may think that the FDA would have requested or would be comfortable with prior preclinical toxicology studies before allowing the conduct of extension tests.
The situation was quite different in the summer of 2018, when company leaders touted positive data from their second phase III study, noting that 43 patients on treatment had a 62.7% decrease in seizures, compared with 1.2% in the placebo group. At that time, the drug became a direct competitor of Epidiolex from GW Pharma, which had impressed the industry with its cannabinoid approach to reducing seizures. This medicine is presented as a blockbuster.
You may remember that fenfluramine, a zogenix-based medicine, was half of the famous Fen-Phen drug. While biotechs have stated that they have not seen cardiovascular problems in their small studies, this begs the question of how far regulators may have raised the bar for approval – or even acceptance of a NDA.
"We remain very confident in the clinical profile of Fintepla demonstrated in the Dravet Syndrome Phase 3 program and are determined to make the product candidate a new treatment option for this rare and often catastrophic epileptic encephalopathy," said the CEO. Stephen Farr.
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