December 20, 2017 / 10:49 PM / 2 years ago

Canada's Aeterna gets FDA approval for growth hormone deficiency test

(Reuters) - Canada’s Aeterna Zentaris Inc said on Wednesday the U.S. Food and Drug Administration has approved its oral test to diagnose adult growth hormone deficiency.

The company said it intends to launch the test, Macrilen, in the United States during the first quarter of 2018.

Macrilen stimulates the secretion of growth hormone, which is then measured via blood samples.

Aeterna said Macrilen is an alternative to the insulin tolerance test, an intravenous test that requires multiple blood draws over several hours.

About 60,000 tests are conducted each year across the United States, Canada and Europe to diagnose adult growth hormone deficiency, the company said.

Symptoms of a deficiency of growth hormone in adults include weight gain, high levels of cholesterol and an increased resistance to insulin.

The company said in November that Macrilen was accepted for review by Europe’s drugs regulator.

Reporting by Tamara Mathias in Bengaluru; Editing by Sriraj Kalluvila

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