FDA places Regeneron and Teva’s pain-drug study on hold
NEW YORK- Regeneron Pharmaceuticals Inc and partner Teva Pharmaceutical Industries Ltd said the U.S. health regulator placed a clinical hold on a mid-stage study of their experimental drug for chronic lower back pain.
The Food and Drug Administration’s (FDA) decision followed a case of a type of joint inflammation in a patient who also had advanced osteoarthritis and was given a high dose of the injectable drug, fasinumab.
The treatment is designed to block nerve growth factor (NGF), a protein involved in transmission of pain signals.
Fasinumab has the potential to be an alternative to opioids, a class of drugs that are effective for pain relief but are frequently associated with addiction, overdose and death.
Following the FDA decision, Regeneron has completed an unplanned interim review of data and has stopped dosing patients, the companies said on Monday.
The unplanned analysis showed clear evidence of efficacy with improvement in pain scores in patients dosed with fasinumab, compared with placebo, after two weeks and one month.
The two drugmakers plan to discuss with the FDA a late-stage study for chronic lower back pain, excluding patients with advanced osteoarthritis.
Fasinumab is also in late-stage development for use in osteoarthritis pain.
Rival drugmakers Eli Lilly and Co and Pfizer Inc plan to seek approval for their similar treatment, tanezumab, by 2018 that is being tested as part of a $1.8 billion collaboration deal in 2013.
Regeneron, best known for blockbuster eye drug Eylea, has been attempting for years to develop an anti-NGF drug for pain, but has been stymied by safety concerns.
The FDA had placed fasinumab and other experimental agents targeting NGF on partial clinical hold in late 2012, after reports that animals on the drugs had suffered nerve damage.
Regeneron’s stock was down about 2 percent at $365 in premarket trading, while Israeli co-developer Teva’s NYSE-listed stock was marginally lower at $42.81. -Reuters