Children Health

Fennec does not expect U.S. approval for hearing loss drug, shares slump

Nov 29 (Reuters) – Fennec Pharmaceuticals Inc (FENC.O) said on Monday it expects the U.S. health regulator to again decline the marketing application for its drug to prevent chemotherapy-induced hearing loss in children, sending its shares tumbling 45%.

The Food and Drug Administration (FDA) indicated that deficiencies have been identified following an inspection of the drug’s manufacturing facility, the company said, without providing further details.

This is the second potential setback for Pedmark, the only clinical drug candidate in Fennec’s pipeline. The FDA had declined to approve the drug last year, citing similar reasons.

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The company resubmitted its application earlier this year, which the regulator accepted for review and set a target action date of Nov. 27 to give its decision.

Administered intravenously, Pedmark is intended for children between one month and 18 years, who have received platinum-based chemotherapy, which uses an agent called cisplatin.

Such therapies are commonly used for the treatment of a range of cancers in children, but can cause permanent hearing loss, which can also affect pediatric cancer survivors.

In two late-stage studies, Pedmark, also under review of the European Medicines Agency, showed that it reduced the incidence of cisplatin-induced hearing loss in children with liver, bone and brain cancer, among others.

Currently, there are no approved therapies for prevention of cisplatin-induced hearing loss in children in the United States.

Over 10,000 children may receive platinum-based chemotherapy in the United States and Europe annually, according to Fennec.

Fennec said on Monday it planned to meet with the FDA to discuss the deficiencies and steps for resubmission of the marketing application once it receives an official decision.

The company’s shares were at $5.30 in premarket trading, after having gained about 29% so far this year to Friday close.

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Reporting by Amruta Khandekar; Editing by Shounak Dasgupta and Sriraj Kalluvila

Our Standards: The Thomson Reuters Trust Principles.

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