FDA issues CRL on Opsumit sNDA

The US Food and Drug Administration has issued a complete response letter (CRL) for the supplemental New Drug Application (sNDA) for Opsumit (macitentan) in the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) to improve pulmonary vascular resistance (PVR) and exercise capacity.

Issued to Actelion Pharmaceutical, a subsidiary of healthcare giant Johnson & Johnson (NYSE: JNJ), the CRL indicates additional data are needed to evaluate the use of Opsumit in the treatment of CTEPH.

Sales of Opsumit in its currently approved indications reached $892 million for the first nine months of 2018.