Shakespeare wrote, “The course of true love never did run smooth,” and San Diego’s Halozyme Therapeutics (NASDAQ: HALO) could say pretty much the same thing about the FDA approval process.
When the FDA said Friday that it was approving HyQvia for adult patients with primary immune disorders, you could practically hear the uplifting music swelling in the background. It was the culmination of an ordeal that began over two years ago, when U.S. health regulators asked Halozyme and Illinois-based Baxter International to halt use of the drug in human patients until additional pre-clinical studies could be completed.
HyQvia is a drug that combines a biologic drug, Baxter’s disease-fighting immunoglobulin product, with Halozyme’s flagship product, a proprietary synthetic enzyme called recombinant human hyaluronidase, or rHuPH20.
Based on the FDA request, Baxter and Halozyme went back to the drawing board. After conducting more tests, the partners amended the Biologics License Application (BLA) they had submitted in mid-2011 with the additional data the FDA had requested. After reviewing the re-submitted BLA, the FDA’s Blood Products Advisory Committee concluded in a 15-1 vote in July that HyQvia “has a favorable risk/benefit profile.”
Based on the FDA’s approval Friday and the strength of the committee’s findings, it would appear that Baxter and Halozyme have mostly allayed the concerns that prompted health regulators to halt clinical studies with HyQvia in 2012. The concerns raised by the FDA in 2012 focused primarily on antibodies that patients were generating against rHuPH20—“and the possible effects of these antibodies on reproduction, [fetal] development, and fertility.” The agency’s September 12 approval letter, which provides advisory warnings and precautions to prescribing doctors, says: “It is unknown whether these antibodies may interfere with fertilization in humans. The clinical significance of these antibodies is not known.”
“With this approval, it’s clear that the FDA feels the risk/benefit profile is acceptable for adults,” Halozyme CEO Helen Torley told me earlier this week. Getting the FDA’s clearance to … Next Page »