FDA Declines Stroke Drug Over Manufacturing and Packaging Issues

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FDA Declines Stroke Drug Over Manufacturing and Packaging Issues

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April 23 (Reuters) - Grace Therapeutics said on Thursday the U.S. Food and Drug Administration declined to approve its drug ⁠for a rare type of stroke, citing deficiencies in chemistry, manufacturing and controls and non-clinical data.

Shares of the ⁠Princeton, New Jersey-based company were down 43%.

In its complete response letter, the FDA referenced specific ⁠issues in the chemistry, manufacturing ‌and controls (CMC) and non-clinical sections of the company's application. Grace said it can address these in a resubmission.

Those issues relate to leachables data for product packaging, non-clinical product toxicology risk assessments and product manufacturing deficiencies at the contract manufacturing organization, ‌the company said.

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The FDA declined Grace Therapeutics' stroke drug approval due to manufacturing and packaging issues. The company plans to address these concerns and seek further guidance from the FDA. Shares dropped 43% following the announcement.

Leachables are chemical compounds that migrate from packaging, manufacturing equipment ​or delivery ‌systems into a drug.

The company said ‌it intends to request a meeting with the FDA to clarify the path forward and determine ⁠the appropriate next steps.

"Potential FDA approval of ... GTx-104 ‌for the treatment of ⁠aSAH would represent the first ​meaningful innovation in the standard of ‌care for these patients in more than 40 years," said Prashant Kohli, Grace's CEO.

The drug GTx-104 is for the treatment of aneurysmal subarachnoid hemorrhage, a critical, ​often fatal form of stroke caused by a ‌ruptured ‌brain aneurysm.

Grace said it is a relatively uncommon type of stroke that accounts for ‌about 5% of all ​strokes and an estimated 42,500 hospital-treated patients in the U.S.

GTx-104 is an injectable formulation of nimodipine, the only FDA-approved drug for aneurysmal subarachnoid ⁠hemorrhage, for intravenous infusion. The IV delivery has the potential to ‌lower drug-to-drug interactions and eliminate potential dosing errors, Grace added.

(Reporting by Puyaan Singh ​in Bengaluru; Editing by Tasim Zahid)

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