Marketing Authorization Application Submitted for Mycapssa for Acromegaly

The European Medicines Agency (EMA) recently received a Marketing Authorization Application (MAA) for Mycapssa, a maintenance therapy for acromegaly. Chiasma submitted the application, basing it on the results of their Phase 3 MPOWERED clinical trial.

MAA for Mycapssa

The MAA was supported by data from the MPOWERED non-inferiority clinical trial, which compared Mycapssa (also referred to as oral octreotide capsules) to long-acting injectable somatostatin analogs (iSSAs). Medical professionals’ goal was to compare the maintenance of biochemical responses in regard to both therapies. Additionally, Chiasma’s treatment has already been approved in the US, demonstrating its potential as a treatment.

More About the Trial

This global, active-controlled, open-label, and randomized trial ran for 15 months. 146 participants enrolled in the trial, all of whom had previously responded to both Mycapssa and iSSAs. Of the 146, 92 responded to Mycapssa and went on to the nine-month controlled phase. They were randomized to either continue with Mycapssa or receive their prior therapy. To evaluate the success of the drug, researchers used time-weighted average of IGF-1 <1.3 x upper limit of normal for their primary endpoint.

Looking Forward

Hopefully, this treatment is able to gain approval in the European Union, as it will provide another treatment option for acromegaly patients. You can read more about it here.

About Acromegaly

Noncancerous tumors called adenomas sit on the pituitary gland in affected individuals with acromegaly, causing it to release an excess of growth hormone (GH). This excess leads to abnormal and significant growth. Symptoms typically appear slowly, with abnormal growth beginning in the appendages and making them disproportionate to the rest of the body. Further symptoms include:

  • Protruding jaw and brow bone
  • Thick, oily skin
  • Excessive sweating
  • Enlarged organs
  • Enlarged nasal bone
  • Enlarged facial features

Surgery is typically the first treatment option, as it is the quickest and most effective option. It may not work for all patients, so other options include dopamine agonists, somatostatin analogs (SSAs), and GH receptor antagonists (GHRAs). In the end, your doctor should individualize your treatment plan to your specific symptoms and needs.

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