Amgen Inc. AMGN announced that it has received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. We expect investors to react negatively to the news.

The company stated that it is currently reviewing the letter and expects to meet with the FDA later this year to discuss the next step. Amgen however stated that the FDA’s response would not impact its regulatory filings in other regions.

We note that in Sep 2015, the company had submitted a Marketing Authorisation Application for Parsabiv for this indication in the EU.

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Parsabiv was added to the company’s portfolio following its acquisition of KAI Pharmaceuticals in 2012.

sHPT, a chronic and serious condition, is estimated to affect two million individuals in the world who receive dialysis. In the U.S., about 468,000 people are said to be suffering from the disease. Approximately 88% of dialysis patients and 79% of patients on hemodialysis are expected to develop sHPT.

We expect investors focus on further regulatory updates from the company on Parsabiv.

Investor should also focus on the upcoming regulatory decision on the company’s supplemental Biologics License Application for Blincyto to include new data to support the treatment of pediatric and adolescent patients suffering from Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. A response from the agency is expected on Sep 1.

Amgen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Actelion Ltd. ALIOF, Anika Therapeutics Inc. ANIK and ANI Pharmaceuticals, Inc. ANIP. Each of these stock sports a Zacks Rank #1 (Strong Buy).

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