|
 Shares of the California-based drug developer plunged nearly 30
percent to $36.50 after it disclosed the FDA's "refusal to file"
letter, which investors could consider as a potential delay in
getting approval for the drug.
Zogenix's drug, to be branded as Fintepla, uses a low-dose, liquid
solution of fenfluramine, which was used in an obesity drug
combination that was withdrawn from the market due to evidence of
heart valve damage.
The FDA, after a preliminary review, cited a lack of certain
non-clinical studies to assess the chronic administration of
fenfluramine and due to an incorrect dataset.
The regulator had not yet asked for any additional clinical trials,
Zogenix said, adding that it plans to meet with the FDA soon.
Zogenix has already filed an application for approval from the
European regulator and a decision is awaited by 2020.
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Current treatment options for Dravet syndrome, which affects an
estimated 20,000 patients in the United States, are limited to a
combination of seizure medication and drugs to prevent emergencies.
Shares of GW Pharmaceuticals Plc, which last July gained approval
for its cannabis-based drug to treat the disorder, were up 4 percent
at $174.30 after the bell.
(Reporting by Manas Mishra in Bengaluru; Editing by Shounak Dasgupta
and James Emmanuel)
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