FDA Slaps Hold on Regeneron, Teva's Pain Drug Fasinumab

FDA Slaps Hold on Regeneron, Teva's Pain Drug Fasinumab October 17, 2016
By Alex Keown, BioSpace.com Breaking News Staff

TARRYTOWN, N.Y. – The U.S. Food and Drug Administration placed a Phase IIb study of fasinumab on clinical hold and asked the company to amend its study protocol. The drug is being studied for the treatment of chronic low back pain and osteoarthritis pain.

The regulatory agency made its request after observing a case of adjudicated arthropathy, a disease of the joint, in a patient receiving high dose fasinumab who had advanced osteoarthritis at study entry, Regeneron and Teva , which are jointly developing the drug, announced this morning. As a result, Regeneron said it completed an “unplanned interim review of results” and stopped dosing patients in the study.

Patients being dosed with fasinumab were grouped into different dosing groups—placebo, 6 mg subcutaneously monthly, 9 mg subcutaneously monthly and 9 mg intravenously every two months.

An analysis conducted by Regeneron and Teva “showed clear evidence of efficacy” regarding pain management in all patients treated with the drug compared to placebo. The companies said safety results are also consistent with expectations. As a result of the analysis, Regeneron and Teva said they intend to design a Phase III study in chronic low back pain that excludes patients with advanced osteoarthritis. The companies plan to submit a pivotal program plan for review with the FDA and other health authorities.

In addition to the Phase IIb trial for chronic low back pain, fasinumab is being studied in a Phase II/III trial for osteoarthritis pain. Regeneron and Teva said a 36-week analysis of the Phase II/III patients showed the incidence of adjudicated arthropathies was found to be potentially dose-dependent. The companies are planning to advance only lower doses in the ongoing fasinumab osteoarthritis pivotal Phase III program, subject to FDA approval.

News of the clinical hold comes one month after Teva dropped $250 million to complete the clinical work of fasinumab and carry it through commercialization. The two companies were forging a deal worth up to $2.6 billion.

Fasinumab is a fully human monoclonal antibody that targets NGF, a protein that plays a central role in the regulation of pain signaling. There is evidence that NGF levels are elevated in patients with chronic pain conditions.

George Yancopoulos, Regeneron’s chief science officer, said the company is making “data-driven decisions on Phase III dosing” and the company believes that will “maximize potential benefit for patients in need, while minimizing the likelihood of side effects.”

Michael Hayden, Yancopoulos’ counterpart at Teva, touted the belief in fasinumab as a treatment for chronic back pain and osteoarthritis pain. He said the companies look forward to advancing the treatment for patients who “have clear unmet need and limited treatment options.”

Shares of Regeneron and Teva dipped slightly this morning after announcing the mid-stage clinical hold.

One of the benefits of fasinumab, if it is approved, could be the reduction of dependence on opioid-based medications to combat acute pain. Opioid prescriptions account for 40 percent of the chronic pain market and carry a well-known risk of abuse and misuse, underscoring the need for alternative pain therapies without the medical and societal challenges.

Regeneron and Teva are not the only companies to jointly develop an anti-NGF. Eli Lilly and Pfizer are developing tanezumab for osteoarthritis pain.

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