Israeli commercial stage biopharmaceutical company Chiasma Inc. (Nasdaq: CHMA) has announced that it has received US Food and Drug Administration (FDA) approval for its MYCAPSSA (octreotide) capsules for long-term maintenance treatment in acromegaly patients. MYCAPPSA is the first treatment for chronic acromegaly that can be taken orally with a pill rather than by injection.
Acromegaly is a hormonal disorder that develops when the pituitary gland produces too much growth hormone in adults. This usually affects middle aged adults whose bones increase in size, including those of their hands, feet and faces.
Chiasma CEO Raj Kannan said, "The FDA approval of MYCAPSSA represents a major therapeutic advancement for people with acromegaly and validation of our TPE delivery platform. We are grateful to patients, healthcare providers, advocates and clinical trial investigators, as well as our employees who have worked diligently to bring MYCAPSSA to people with acromegaly. As we move into this next exciting phase as a commercial company, we are prepared to execute on a successful U.S. launch by working with healthcare providers to bring MYCAPSSA to as many patients who could benefit from it."
The company expects MYCAPSSA to be commercially available in the fourth quarter of 2020 subject to FDA’s timely approval of a planned manufacturing supplement to the approved NDA.
Despite the report Chiasma's share price fell 7% on Friday, giving a market cap of $257 million.
Published by Globes, Israel business news - en.globes.co.il - on June 29, 2020
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