Zogenix Launches Global Program to Boost Access to Fintepla
In the United States and the European Union, Fintepla is approved as an add-on treatment to help prevent seizures in people with Dravet syndrome, ages 2 and up. According to Zogenix, the new expanded access program will give physicians in other parts of the world — including parts of Europe where reimbursement has not yet been established — access to the therapy, where local regulations allow.
Physicians interested in accessing the therapy for their patients through the program can get more information by emailing [email protected].
“Physicians in many countries have expressed interest in Fintepla for their patients,” Bradley S. Galer, MD, executive vice president and chief medical officer at Zogenix, said in a press release. “We are pleased to be able to take this step to support their requests and help more patients in need.”
To help manage the new program, Zogenix has partnered with Durbin, a part of Uniphar Group’s Product Access Division, and a leading specialist in distributing specialized medicines internationally.
“We are delighted to be working in partnership with Zogenix on this important access program,” said Dan Piggott, managing director of Uniphar Group’s Product Access Division. “We look forward to helping facilitate broader access to Fintepla for patients with critical unmet medical needs.”
Although the exact biological mechanism by which Fintepla acts is not fully understood, data from several clinical trials have demonstrated that the treatment can substantially reduce the frequency of seizures in people with Dravet syndrome. Clinical trials also showed the medication has an acceptable safety profile. Common side effects include diarrhea, constipation, decreased appetite, drowsiness and lethargy, problems with coordination and balance, and increased blood pressure.
Fintepla may increase the risk of certain heart conditions, so tests to monitor for heart problems are typically required before starting therapy, routinely while on the medication, and after stopping treatment.
“Randomized clinical studies have demonstrated Fintepla’s ability to provide transformational and durable seizure reduction for many Dravet syndrome patients whose seizures were not adequately controlled despite treatment with one or more other anti-epileptic medicines,” Galer said.