April 15th marks the deadline for the FDA to approve or deny approval for Mycapssa, a drug created by biotech company Chiasma.
Mycapssa is pending approval for the treatment of Acromegaly after a study in 2014 involving 155 patients. The currently approved treatments are regular injections that control growth hormones (Sandostatin and Somatuline Depot).
Mycapssa would be taken in pill form and holds the promise of more consistent dosing
and eliminating the chance of site reactions post-injection. There are currently late stage trials being conducted in Europe to lead to approval there.
The yearly cost of the drug is expected to be competitive with the currently approved drugs, which range from 45,000 to 60,000 dollars.
Due to the rarity of the disease (around 70,000 people worldwide), however, the company’s main source of profit from the drug would be from its potential introduction (in 2019) to the neuroendocrine cancer market.
Patient Worthy representatives will be attending the Acromegaly conference April 29th – May 1st in Chicago and will be live tweeting on-site. Hopefully by then we will have also announced Mycapssa’s approval. Keep an eye out for these timely updates!
Read more about Chiasma and Mycapssa here.