Halozyme's Hylenex NDA accepted by FDA

US drugmaker Halozyme Therapeutics says that the US Food and Drug Administration has accepted a New Drug Approval application for its drug absorption facilitator, Hylenex (rHuPH20), formerly known as Enhanze SC.

The SanDiego-headquartered firm submitted the NDA on March 23 for its recombinant hyaluronidase, seeking approval for its use as a spreading agent to facilitate the dispersion and absorption of other injected drugs. The priority status, which the agency granted in April, sets the target date for initial FDA action within six months from the date of submission.

The company sees Hylenex as an alternative to animal-derived hyaluronidases. On the day of the announcement, Thursday May 26, Halozyme's shares rose 2.6% to close at $2.0 per share.