Research-based pharmaceutical company Camurus has received a Complete Response Letter (CRL), i.e. a request for additional information from the US Food and Drug Administration (FDA) regarding the application for marketing authorization for CAM2029 for the treatment of acromegaly. This is stated in a press release.
The decision is said to be related to deficiencies identified during an inspection of a contract manufacturer's facility. The request includes new additional remarks, for example related to clinical efficacy or safety data for CAM2029.
"The FDA's decision is regrettable. Our application for marketing authorization is supported by strong clinical data demonstrating the potential of CAM2029 to address important unmet medical needs for patients with acromegaly. Camurus will work with the FDA and the contract manufacturer to make CAM2029 available to patients with acromegaly as soon as possible," said Fredrik Tiberg, CEO of Camurus.
Camurus AB is a Sweden-based research and development based pharmaceutical and biotechnology company with a focus on the development and marketing of specialty medicines, providing patients suffering from severe and chronic disease, such as opioid dependence, pain, cancer, and endocrine diseases. The Company has a diversified research portfolio, which includes products in clinical trials. The Companyâs products are based on FluidCrystal formulation technology. FluidCrystal is Company's patent-protected technology platform. Camurus AB is the parent company of the Group, which comprises of legal entities, namely: Camurus Inc, Cubosome Inc, Development AB, Camurus GmbH, Camurus Ltd, Camurus Oy, Camurus AS, Camurus SAS, Camurus Pty Ltd, Camurus S.L, Camurus ApS, Camurus BV and Camurus Austria GmbH.
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