FDA accepts filing NDA from Chiasma Pharma for octreotide capsules to treat acromegaly- Roche + Genentech

The FDA has accepted for filing the NDA for the marketing and sale of octreotide capsules from Chiasma Pharma for the maintenance therapy of adult patients with acromegaly. The FDA is expected to inform the company of the PDUFA date by the end of August. The NDA was submitted utilizing the FDA's 505(b)(2) regulatory pathway.

Roche and Chiasma Pharma entered into an agreement to develop and commercialise Chiasma’s proprietary product Octreolin, initially for acromegaly and subsequently for neuroendocrine tumours. Octreolin is an investigational oral form of the peptide octreotide, a somatostatin analogue that is commercially available only by injection. Octreolin has completed a pivotal phase III clinical trial for acromegaly. Under the terms of the agreement, Roche received a worldwide exclusive license to Octreolin, and will assume responsibility for its commercialisation. Genentech will market the product in the United States.

Comment: Treatment with Sandostatin LAR (depot formulation of octreotide acetate), a monthly IM injection, is the most common treatment of choice for acromegaly. Octreotide is effective for 95% of patients; approximately 65% and 30% of patients show a complete or partial response, respectively. However, the injections cause discomfort and pain, with 30% to 50% of patients reporting pain at the injection site (for doses of 20 mg and 30 mg Sandostatin LAR). Patients can also suffer from welts that take a considerable period of time to disappear. In addition, patient needle-phobia can manifest itself in non-compliance as well as stress and anxiety for those who ultimately do take the injections. Furthermore, the octreotide long-acting injections require complex reconstitution and caregivers’ assistance.