Acromegaly Maintenance Rejected by FDA


Approval was sought for octreotide (Mycapssa) capsules for the maintenance treatment of adults with acromegaly.

The FDA has rejected Chiasma Inc’s octreotide (Mycapssa) capsules for the maintenance treatment of adults with acromegaly.

Earlier this month, Chiasma received a complete response letter citing that the application was not ready for approval in its present form.

“We are surprised, disappointed, and respectfully disagree with the FDA’s decision,” said Mark Leuchtenberger, president and CEO of Chiasma, in a press release. “The FDA has encouraged us to request an end-of-review meeting with the agency to discuss the path forward, and we will do so.”

The FDA told Chiasma that it had not provided enough evidence of the drug’s efficacy to warrant an approval and advised that the company conduct an additional clinical trial to collect sufficient data.

The FDA received data from a single-arm, open-label phase 3 clinical trial, but the administration would like to see a randomized, double-blind, and controlled trial involving US patients. The FDA also asked that the trial be long enough to show that the control of the disease is stable for the primary efficacy assessment.

In addition, deficiencies were noted during a site inspection, and one of Chiasma’s suppliers was notified of this.

No safety concerns were listed in the FDA’s complete response letter.

“We continue to believe in the potential for Mycapssa to help many patients with this orphan disease, and we intend to work diligently on their behalf to obtain US approval,” Leuchtenberger said in the press release. “In the meantime, we are proceeding with our recently initiated MPOWERED phase 3 trial comparing the safety and efficacy of Mycapssa with monthly somatostatin analog injections to support a potential marketing authorization application with the European Medicines Agency.”

Related Videos
Woman with pink ribbon on color background. Breast cancer awareness concept | Image Credit: Pixel-Shot -
Pharmacy, medicine and senior woman consulting pharmacist on prescription. Healthcare, shopping and elderly female in consultation with medical worker for medication box, pills or product in store- Image credit: C Daniels/ |
View in microscopic of pathology cross section tissue ductal cell carcinoma or adenocarcinoma diagnosis by pathologist in laboratory | Image Credit: arcyto -
A female doctor sits at her desk and talks to a female patient while looking at her mammogram | Image Credit: lordn -
Doctor holding a digital tablet with x-ray of brain and skull skeleton. Headache, meningitis and migraine concept - Image credit: Steph photographies |
Woman Physician Talking With Her Patient | Image Credit: LStockStudio -
A health visitor explaining a senior woman how to take pills - Image credit: Halfpoint |
Diabetes patient turn knob on end of insulin pen and dial up correct insulin dose for injection. Scale window on pen syringe showing number of units dose. Medical equipment is easy to self injection - Image credit: Orawan |
© 2023 MJH Life Sciences

All rights reserved.