Lilly and Pfizer Halt Global Development of NGF Inhibitor Tanezumab Following Regulatory Rejections

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Recently, Eli Lilly disclosed an important update in its third-quarter financial report. In October of this year, the company and its partner Pfizer terminated the global clinical development program for the antibody drug tanezumab, a nerve growth factor (NGF) inhibitor developed for the treatment of osteoarthritis pain.

According to information disclosed by Eli Lilly, both parties made the aforementioned decision primarily because tanezumab has encountered significant regulatory setbacks in both the U.S. and Europe. In the U.S., the FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for tanezumab for the treatment of osteoarthritis (OA); in the EU, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion on the Marketing Authorization Application (MAA) for tanezumab for the treatment of OA.

Analysts have pointed out that the termination of this project represents a major setback for the development of NGF inhibitor-class drugs, further prolonging the bleak period for the development of this class of drugs.

In fact, as early as 2011, the U.S. FDA placed a clinical hold on the NGF class due to evidence linking these drugs to joint damage and other adverse events. In the years following the FDA's action, companies including AbbVie, AstraZeneca, and Johnson & Johnson successively discontinued their research on NGF inhibitors. However, a small number of pharmaceutical companies persevered, ultimately leading Eli Lilly and Pfizer to seek approval for tanezumab for the treatment of OA.

The continued development of NGF inhibitors has long been regarded as a high-risk, high-reward endeavor. For Eli Lilly and Pfizer, evidence that this gamble would not pay off emerged earlier this year. At that time, the U.S. FDA and the European EMA successively rejected the approval requests.

Eli Lilly has now confirmed that tanezumab has reached the end of its development lifecycle, and the company, together with Pfizer, has decided to completely abandon and terminate the global clinical development program for tanezumab. The massive investments both parties made in the tanezumab project have ultimately come to nothing.

At an investor event, Angela Hwang, President of Pfizer Biopharmaceuticals Group, stated that the dossier submitted to the FDA for the tanezumab program may contain "the largest volume of data Pfizer has ever submitted to date." The size of the submission reflects a lengthy development process and a complex risk-benefit profile.

Eli Lilly and Pfizer’s decision to terminate the development of tanezumab has further weakened what was once a vibrant pipeline. Regeneron continues to collaborate with Teva on the NGF inhibitor fasinumab, but the comprehensive rejection of Eli Lilly and Pfizer’s tanezumab by US and European regulatory authorities has further diminished Regeneron and Teva’s expectations for fasinumab.

In April this year, Teva CEO Kare Schultz told investors that the FDA advisory committee’s vote against tanezumab was “certainly negative for this class of drugs.” He added that non-essential spending on fasinumab has been suspended pending a decision on whether to seek regulatory approval.

Source: Lilly, Pfizer stop development of osteoarthritis drug after FDA rejection, extending bleak run for NGF inhibitors