September 10, 2013 / 10:48 PM / in 4 years

FDA demands OvaScience apply for product approval; shares slump

Sept 10 (Reuters) - OvaScience Inc, a developer of infertility treatments, said it plans to suspend enrollment in a U.S. study testing its lead product after regulators sought an application for the product’s approval, sending the company’s stock down 44 percent.

OvaScience’s Augment is being developed as a low-risk human cellular and tissue-based product (HCT/P), which requires no regulatory approval for testing or marketing.

The product is being tested in a human study to help improve egg quality and increase the success of in-vitro fertilization.

However, the company said the FDA questioned the status of Augment as an HCT/P in a letter sent on Friday.

The agency also sought an investigational new drug application (IND) for Augment.

An IND is reviewed by the FDA to check if a product is safe for research subjects. It is a precursor to clinical testing of drugs that are eventually pitched to the FDA for marketing approval.

The company said it expects to have further talks with the FDA and present details on Augment’s qualifications as an HCT/P.

In a similar regulatory intervention on Sept. 4, the FDA said MiMedx Group Co’s human-tissue derived products did not have appropriate regulatory approvals and needed to be deemed safe and effective by the agency before being sold.

OvaScience now plans to start sites for a study of Augment in select countries outside of the United States in 2014.

The Cambridge, Massachusetts-based company’s shares fell to a low of $8.30 in extended trading. They closed at $14.27 on the Nasdaq on Tuesday. (Reporting by Zeba Siddiqui in Bangalore)

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