Fennec Pharma expects FDA to decline application for hearing loss drug

[November 29, 2021]  (Reuters) -Fennec Pharmaceuticals Inc said on Monday it expects the U.S. Food and Drug Administration (FDA) to decline the marketing application for its drug to prevent chemotherapy-induced hearing loss in children.

The company's shares fell 29.6% to $6.79 in premarket trading.

The FDA has indicated that deficiencies have been identified after the regulator's inspection of the drug's manufacturing facility, the company said.

Fennec's drug Pedmark, which is administered intravenously, is intended to be used in children between one month and 18 years old.

Over 10,000 children may receive platinum-based chemotherapy in the United States and Europe annually, according to Fennec. Pedmark aims to counter the harm caused by platinum-based therapies, which use a compound called cisplatin, the company said.

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

The health regulator was expected to take a decision on the drug by Nov. 27.

(Reporting by Amruta Khandekar; Editing by Shounak Dasgupta)

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