Israeli biodrug company Chiasma (CHMA) saw its share price has more than halved in reaction to the U.S. Food and Drug Administration (FDA) decision to reject its drug Mycapssa (octreotide) for treatment of acromegaly (giantism), Globes reported on Monday.
Chiasma announced that it had received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for Mycapssa capsules for the maintenance treatment of U.S. adult patients with acromegaly, withholding approval for the drug.
The company’s share price loss more than 50 percent, and it has a current market cap of some $100 million.
“The FDA advised Chiasma that the Agency did not believe the company’s application had provided substantial evidence of efficacy to warrant approval, and advised Chiasma that it would need to conduct another clinical trial in order to overcome this deficiency,” Chiasma stated.
Chiasma added that “the FDA did not note any safety concerns related to Mycapssa in its letter.”
The trial that the FDA recommends is liable to mean a long delay in approval for the product, and to cost many tens of millions of dollars.
Chiasma set out to demonstrate that Mycapssa is as effective as Novartis’s treatment Signifor, but did not do so to the FDA’s satisfaction.
Chiasma said in response: “The FDA expressed concerns regarding certain aspects of the company’s single-arm, open-label Phase 3 clinical trial and strongly recommended that the company conduct a randomized, double-blind and controlled trial that enrolls patients from the United States and be of sufficiently long duration to ensure that control of disease activity is stable at the time point selected for the primary efficacy assessment.”
“We are surprised, disappointed and respectfully disagree with the FDA’s decision,” said Chiasma president and CEO Mark Leuchtenberger today. “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.