The world's first octreotide capsule was approved by the FDA!

MYCAPSSA is suitable for long-term maintenance treatment of patients with acromegaly who respond to octreotide or lanreotide and tolerate treatment

On June 26, 2020, Chiasma, Inc. (NASDAQ: CHMA) announced that the US Food and Drug Administration (FDA) approved MYCAPSSA® (Octreotide capsules) for octreotide or Lanreotide the long-term maintenance treatment of acromegaly patients with peptides (lanreotide) that are responsive and resistant to treatment. MYCAPSSA is the first and only oral somatostatin analogue (SSA) approved by the FDA, and the first product approved by the FDA to use Chiasma's transient permeability enhancer (TPE®) technology. Acromegaly is a rare chronic disease, usually caused by a benign pituitary tumor, which is characterized by excessive production of growth hormone and INSULIN-like growth factor-1 hormone, often treated by long and heavy injections. If left untreated, acromegaly can cause serious illness and sometimes life-threatening. The company estimates that in the United States, approximately 8,000 patients are receiving injectable somatostatin analogs (SSA).

Chiasma CEO Raj Kannan said: "FDA approval of MYCAPSSA represents a significant treatment advancement for patients with acromegaly and validates our TPE delivery platform." "We thank patients, healthcare providers, advocates and clinical Experimental researchers, and our employees who work diligently to bring MYCAPSSA to patients with acromegaly. As we enter the next exciting stage as a commercial company, we plan to successfully implement it in the United States by working with healthcare providers, Bring MYCAPSSA to as many patients as possible who can benefit from it."

Acromegaly Community, Inc. President Jill Sisco said, "People with acromegaly face many challenges related to injectable therapies and need new treatment options. The entire acromegaly community has been waiting for oral treatment options, which It’s gratifying to see that the FDA has now approved the first oral SSA treatment, which may have a major impact on the lives of patients with acromegaly and their caregivers."

The company hopes that MYCAPSSA will be available in the fourth quarter of 2020, but it will receive FDA's timely approval of the planned manufacturing supplement of the approved NDA. Chiasma plans to expand its customer-facing team in terms of sales, patient services, and market access, with approximately 45 employees. To help patients switch to MYCAPSSA, Chiasma plans to provide a range of patient support services ranging from insurance provider and professional pharmacy assistance to providing support to patients to help seamlessly integrate MYCAPSSA into their daily lives. The company believes that patients, doctors, nurses and payers will appreciate the huge benefits of MYCAPSSA. To ensure that patients have widespread access to this innovation, Chiasma plans to price MYCAPSSA competitively with the fastest growing SSA in the American acromegaly market to reflect the value MYCAPSSA provides to the healthcare system.

FDA approves MYCAPSSA as a randomized, double-blind, placebo-controlled, octreotide capsule-based, 9-month positive result of the 3-month CHIASMA OPTIMAL clinical trial, which reached the primary endpoint and all four secondary endpoints, as well as from Chiasma All safety data for all phase 3 clinical trials of MYCAPSSA. The MYCAPSSA prescription information describes the following important adverse reactions: cholelithiasis and complications of cholelithiasis; hyperglycemia and hypoglycemia; abnormal thyroid function; abnormal cardiac function; and reduced vitamin B12 levels and abnormal Schilling test.