Clinigen division teams up with TESARO

Clinigen Group announced on Tuesday that its Idis Managed Access division has partnered with TESARO to launch a managed access program for the investigational PARP 1/2 inhibitor, niraparib.

The AIM-traded company said Niraparib is being made available for eligible women in the U.S. with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following a complete or partial response to platinum-based chemotherapy.

Clinigen said niraparib is an oral, once-daily PARP 1/2 inhibitor administered following a response to platinum-based chemotherapy, which may address the difficult ‘watchful waiting’ periods experienced by patients with recurrent ovarian cancer after the completion of chemotherapy, in between cycles of platinum-based chemotherapy.

Niraparib has been accepted for priority review by the US Food and Drug Administration.

The managed access program allows physicians to request niraparib for individual, eligible US patients who may not be able to participate in a clinical trial nor have any other treatment option, but who may benefit from access to this investigational therapy prior to approval.

“As the global leader in providing access to unlicensed medicines, we have delivered over 220 managed access programs which have benefited thousands of patients,” said Clinigen chief commercial officer North America and Europe, Steve Glass.

“There is a clear area of unmet medical need in the treatment of ovarian cancer, the fifth most common cause of death from cancer among women in the US.

“We are pleased to be partnering with TESARO to deliver this managed access program for niraparib, providing women with the opportunity to gain access to this important investigational therapy at the earliest possible moment.”