The FDA issued a complete response letter to Camurus, dealing a setback to the Swedish drugmaker’s efforts to bring its treatment for the hormonal disorder acromegaly to market because of problems with a third-party manufacturer.
The rebuke is for the company’s CAM2029 (octreotide) extended-release injection to treat patients with acromegaly, which is a rare hormonal disorder that causes the body to produce too much growth hormone that can cause abnormal growth of the hands, feet, face and other parts of the body. The company submitted its new drug application for the treatment late last year.
The base drug octreotide acetate for injection was first approved by the FDA in 1988 from Novartis under the name Sandostatin.
In its letter, the FDA cited “facility-related deficiencies” the agency found during a September inspection of the unnamed third-party production site. No other concerns, including clinical efficacy or safety of the drug, were cited by the regulatory agency in the CRL, the company said in an Oct. 22 press release.
“The CRL is disappointing, however, we are confident in the data supporting our NDA and the potential of CAM2029 to address unmet medical needs of patients with acromegaly,” Fredrik Tiberg, Camurus’ president and CEO, said in the release. “Camurus is committed to working with the FDA and the third-party manufacturer to bring CAM2029 to patients living with acromegaly as soon as possible.”
The news sent shares of Camurus down more than 12% in trading on the Swedish NASDAQ Tuesday to as low as 566.50 Swedish kronor ($53.74).
The drug is currently under EU review for market authorization, the company said, adding that two other development programs for CAM2029 are underway that target gastroenteropancreatic neuroendocrine tumors and polycystic liver disease.
According to clinical studies by Camurus, CAM2029 (which is based on the company’s FluidCrystal technology) has the potential to deliver increased bioavailability and octreotide exposure compared to current market-leading products. The treatment is designed to enable easy self-administration through a prefilled pen.