The safety issue of Pfizer/Lilly's new painkiller tanezumab triggers FD...

CompileKe Ke

Although clinical trials have proven that Pfizer and Eli Lilly’s anti-NGF osteoarthritis drug tanezumab can be used to treat patients with osteoarthritis, a new briefing document issued by the US FDA still raises serious safety issues for the drug.

The main safety issue associated with the drug is the occurrence of rapidly progressive osteoarthritis (RPOA), which Pfizer and Eli Lilly have observed in their studies.

But despite these good intentions, the US FDA still stated in the review document that “the proposed REMS is not enough to reduce the risk of RPOA, nor can it ensure that the benefits of tanezumab outweigh the risk of RPOA disease.

The US FDA added, “Although the two companies have proposed clinical risk mitigation strategies in the study, the risk of RPOA is still worrying, because a considerable number of patients with adverse events require total joint replacement.

In addition, the U.

According to reports, the development of tanezumab spans 15 years, and its research new drug application was first submitted in April 2004.

In April 2019, Pfizer and Eli Lilly announced the latest results of a Phase III clinical trial of 3021 people with moderate to severe knee or hip osteoarthritis.

Compared with the patient group receiving only non-steroidal anti-inflammatory drugs, the tanezumab treatment group also had more safety events.

In addition, there is evidence that if non-steroidal anti-inflammatory drugs and tanezumab are used at the same time, the risk of joint destruction will increase by 2-3 times.

In October 2020, Pfizer and Eli Lilly announced that tanezumab has achieved consistent results in relieving pain and improving physical function in several phase III trials of osteoarthritis.

The researchers explained: "The adverse events of possible decline in sympathetic nerve function are balanced among the treatment groups.

According to this latest briefing document, the US FDA has not yet made a final decision on the REMS applications of Pfizer and Eli Lilly.

Reference source: FDA Cites Safety Concerns Over Pfizer and Lilly's Osteoarthritis Drug Tanezumab