Chiasma Announces FDA Acceptance of MYCAPSSA® New Drug Application Resubmission
“The FDA acceptance of our NDA resubmission marks the achievement of the first planned 2020 milestone for Chiasma and is a significant step towards making MYCAPSSA available to eligible patients,” said Raj Kannan, Chief Executive Officer of Chiasma. “If approved, we believe MYCAPSSA, as the first oral somatostatin analog, has the potential to change the standard of pharmacological care in the management of patients with acromegaly. We look forward to working with the
Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. We believe that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analogs in the
Chiasma is focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. In
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the company’s development of octreotide capsules, conditionally named MYCAPSSA, for the treatment of acromegaly, statements regarding the timing of regulatory review and potential approval, statements concerning the nature of the FDA’s review of the NDA resubmission, statements concerning the commercial or therapeutic potential of MYCAPSSA, if approved, including the potential to change the standard of pharmacological care in the management of patients with acromegaly, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company’s control, that may cause actual events or results to differ materially from the company’s current expectations. For example, there can be no guarantee that the
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Source: Chiasma, Inc.