US FDA extends review of Ascendis Pharma's hormone disorder therapy

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S.

(Reuters) -The U.S. Food & Drug Administration has extended its review of Ascendis Pharma's therapy to treat adult patients with a hormone disorder by three months, the company said on Tuesday.

U.S.-listed shares of the company were down 6.6% in late afternoon trading.

The health regulator notified that data submitted for the ongoing review of the therapy, called TransCon PTH, constituted "a major amendment" to the company's application seeking market approval.

Last year, the FDA declined to approve the Danish drugmaker's once-daily therapy, TransCon PTH, citing concerns linked to manufacturing controls of the drug and device combination.

The FDA, however, did not express any concerns about the clinical data submitted at that time and did not seek fresh pre-clinical or late-stage trials in its so-called complete response letter.

The FDA is now set to make its decision known by Aug. 14.

Ascendis CEO Jan Mikkelsen said the company has responded to all requests received to date from the FDA and will work with the agency as it continues its review.

The disorder known as hypoparathyroidism is caused by the absence of the parathyroid hormone that regulates calcium and phosphorus levels in the body.

The disorder causes low calcium levels and high phosphorus levels in the blood, in which patients suffer from muscle cramps, seizures and long-term symptoms such as high risk of kidney disease and depression.

The current standard-of-care treatment for the condition is the daily intake of vitamin D and calcium supplements.

Tokyo-listed drugmaker Takeda's Natpara was the only approved treatment for this condition, but unresolved supply issues have resulted in discontinuation of the treatment.

Ascendis' therapy, marketed under the name Yorvipath, gained approval in UK in April. It is already available in Germany and Austria and had first-quarter sales of 1.5 million euros ($1.62 million) for the first two months since its launch.

($1 = 0.9244 euros)

(Reporting by Sriparna Roy and Sneha S K in Bengaluru; Editing by Krishna Chandra Eluri and Shailesh Kuber)