FDA Rejects Amgen, Inc. (NASDAQ:AMGN) Osteoporosis Drug, Requests More Data

-
0
FDA Rejects Amgen, Inc. (NASDAQ:AMGN) Osteoporosis Drug, Requests More Data

The Food and Drug Administration has issued a complete response letter for Amgen, Inc. (NASDAQ:AMGN) bone-boosting drug Evenity. The regulator has since asked the company to submit safety and efficacy data from two pivotal phase III studies for further review.

FDA Resubmission Requirements

The complete response letter is a major blow for Amgen which was planning to market the bone boosting drug as a treatment for postmenopausal women with osteoporosis.

“During our interactions with the FDA, we agreed that the ARCH data should be considered in the regulatory review prior to the initial marketing authorization and, as a result, anticipated this request,” said Sean Harper, Amgen’s President of Research and Development

The next submission will have to include efficacy and safety data from the BRIDGE study that assessed Evenity in Men with Osteoporosis. The study met its primary endpoint in demonstrating that the drug can reduce bone mineral density at the lumbar spine in male patients.

The company will also have to include data from Phase III active comparator ARCH study that showed Evenity led to a significant fracture risk reduction compared to Merck & Co., Inc.(NYSE:MRK) Fosamax. Fosamax is currently the standard of care in osteoporosis.

However, cardiovascular events experienced during the ARCH study threaten to derail approval. Amgen has already indicated that it does not expect the drug to be approved this year given the safety concern that first needs to be addressed.

Kyprolis NDA Application

Separately, Amgen has made a New Drug Application to the FDA for its myeloma drug Kyprolis. The company has also made a marketing application to the European Medicine Agency. The applications seek to expand the drug’s label to include survival data from Phase III endeavor study.

Kyprolis is currently approved for use in combination with dexamethasone or Celgene Corporation (NASDAQ:CELG)’s Revlimid in patients with refractory multiple myeloma. It is also the first treatment to achieve overall survival in a head to head comparison with standard care. Endeavor study results indicate that the drug significantly reduced the risk of death by up to 21% compared to Velcade.