The FDA handed a CRL to the Swedish biotech Camurus for its hormone disorder therapy over “facility-related deficiencies” at a third-party manufacturer.
The therapy, dubbed CAM2029, had a PDUFA date of Oct. 21 for acromegaly, but production issues were found at a third-party factory in September. There were no issues with the candidate’s efficacy or safety, Camurus said in a Tuesday release.
CAM2029 does not have a new decision date, but Camurus said “timely resolution of the CRL” will depend on the unnamed third-party manufacturer’s responses. Labeling discussions for the asset were already in the final stages when the CRL was given, the company said.
Acromegaly occurs when the body makes too much growth hormone, which leads to abnormally large hands and feet. Subcutaneously administered CAM2029 features a peptide inhibitor of growth hormones called octreotide.
Camurus announced data from a pair of Phase 3 trials investigating CAM2029 in June and July 2023, showing acromegaly symptoms improved in patients. In May, Camurus said the EMA had received its regulatory application.
CAM2029 attracted interest from Novartis in 2011 when the company put down $10 million upfront for an option to license the treatment for acromegaly and other neuroendocrine tumors (NETs). Novartis exercised the option in 2013, but returned the rights in 2018 citing “commercial reprioritization.”
Jefferies analysts said the delay could lead to Camurus launching its drug later than expected. Crinetics Pharmaceuticals has its own acromegaly candidate and announced the submission of its FDA application last month.
CAM2029 is also being investigated for gastroenteropancreatic neuroendocrine tumors and polycystic liver disease.
Nicole DeFeudis contributed reporting.
Editor’s Note: This story has been updated to include additional background on the CAM2029 program.