Chiasma’s new drug for growth disorder treatment rejected by US FDA
Chiasma, Inc., a late-stage biopharmaceutical company that is focused on improving the lives of patients with rare and serious chronic diseases, announced on April 15 that the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)regarding the company’s New Drug Application for Mycapssa (octreotide) capsules.
The CRLs are issued by the FDA CRLs to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.
Mycapssa is an investigational new oral drug proposed for the maintenance therapy of adult patients with acromegaly.If approved, octreotide capsules may be the first oral somatostatin analog approved for acromegaly.
Acromegaly, a condition caused by excessive growth hormone, can lead to the enlargement of body parts, including hands, feet and facial features. This disorder can result to serious illness and premature death.
Chiasma is reviewing the FDA communication and plans to provide an additional update.
Source: Chiasma Pharma
Category: Features, Pharmaceuticals
