For a drug to enter the market, manufacturers must conduct extensive research and testing to ensure the medication does as they designed it to and is safe to use. Once completed, they must then submit their findings to the U.S. Food and Drug Administration for further testing to verify that the drug is safe and effective. If they confirm the results, they will approve the drug.

Pfizer (Xeljanz’s manufacturer) had to go through this exact process. The FDA did initially approve Xeljanz for rheumatoid arthritis in 2012. They later approved Xeljanz for psoriatic arthritis and ulcerative colitis. Most recently, they approved it for polyarticular course juvenile idiopathic arthritis (pcJIA). However, Pfizer didn’t just stop with FDA approval.

The drug manufacturer also tried to get Xeljanz approved for use in Europe. However, they did not meet the same results. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) opted not to approve tofacitinib (the active ingredient in Xeljanz) for rheumatoid arthritis. This denial of Xeljanz stopped the drug from entering the European market.

The FDA released the results of an interim analysis after their initial approval. The results revealed an increased risk of blood clots and death. Naturally, this has led to a host of lawsuits against Pfizer. If you or someone you love suffered injuries while taking Xeljanz, contact Wormington & Bollinger and let us fight for the justice you deserve.

Europe’s Version of the FDA

The FDA approved Xeljanz for rheumatoid arthritis in 2012, which was the first for Xeljanz. After Pfizer received this approval, they continued pushing authorization in other areas of the world, namely Europe. The drug manufacturer submitted their data in Europe near the beginning of 2013.

The European Medicines Agency (EMA) is a decentralized agency in the European Union tasked with the scientific evaluation, supervision, and safety monitoring of all drugs in the EU. Their goal is to ensure that all medicines available in the EU market are safe to use, of high quality, and do as advertised. The EMA is the EU’s equivalent of the FDA.

Within the EMA is the Committee for Medicinal Products for Human Use (CHMP). This group is in charge of ensuring that human medicines are safe and effective. The CHMP plays a pivotal role in approving drugs in the EU.

The CHMP’s responsibility is to conduct assessments in the process of reviewing the evidence to support medicinal products (drugs, medical devices, etc.) in relation to marketing. They also play a role in evaluating medicines that have already been authorized at a national level. Finally, they provide scientific advice to companies researching and developing new drugs, create scientific guidelines and regulations to help manufacturers prepare for authorization, and much more.

The CHMP plays a significant role in the approval of medications, determining whether a drug meets the quality, safety, and efficacy requirements through scientific evaluation. They also ensure that the medical benefits outweigh the risks.

Pfizer had to submit their data regarding Xeljanz to the CHMP for approval. However, the CHMP voted not to recommend marketing authorization of tofacitinib.

The EMA’s Denial of Xeljanz

The CHMP decided not to approve marketing authorization for tofacitinib as a treatment for moderate to severe cases of rheumatoid arthritis in April 2013. However, Pfizer then requested a re-examination of the EMA’s opinion later that year. After reviewing their initial recommendations, they confirmed the refusal of authorization on July 25, 2013.

The organization concluded that the risks of taking tofacitinib did not outweigh the benefits. They based their decision on data from five studies involving more than 3,300 patients with rheumatoid arthritis. It compared tofacitinib (both the 5-mg and 10-mg twice-daily doses) with placebo, either by itself or with other backgrounds disease-modifying antirheumatic drugs (DMARDs).

The main measures of effectiveness were changes in patient scores for signs and symptoms of disease, physical function, joint structural damage, and activity of disease. They measured them after three or six months, depending on the study.

CHMP’s Explanation

The CHMP had significant concerns regarding the risk and type of serious infections seen while taking Xeljanz. These risks were related to the immunosuppressant function of the drug. They were also concerned about other adverse reactions, including certain cancers, gastrointestinal perforations, liver damage, and increased lipid levels in the blood. The committee was unsure whether healthcare professionals would be able to manage theses risks successfully.

In April 2013, the CHMP concluded that the data showed tofacitinib improved disease signs and symptoms and physical function. However, they also felt that there was insufficient evidence showing that the drug consistently reduced disease activity and structural joint damage, especially in patients taking a 5-mg dose when at least two other DMARDs were unsuccessful.

Pfizer then requested that the CHMP remove the claims regarding structural damage from their indication. However, after further review, the CHMP still believed that the medical benefits did not outweigh the safety concerns. The committee then reaffirmed their recommendation for refusal of marketing authorization.

Filing a Dangerous Drug Lawsuit

The FDA did approve Xeljanz for rheumatoid arthritis before the EMA’s denial of Xeljanz, which meant Americans could take the drug. However, in recent years, more and more lawsuits have emerged against Pfizer for injuries sustained while taking this drug. In some cases, the EMA’s denial can be used against Pfizer.

Many lawsuits have claimed Pfizer failed to warn doctors and patients about the risks of the drug. While Pfizer might deny these claims, the denial of Xeljanz they received from the EMA tells a different story. The committee advised Pfizer about these findings, and they advised patients not to take higher doses of this drug. However, Pfizer did not communicate these findings to American patients.

Pfizer has come under fire in recent years. After the FDA unveiled the results of their interim analysis, even more lawsuits emerged. If you or someone you loved suffered injuries while taking Xeljanz, contact the dangerous drug attorneys at Wormington & Bollinger today. Let us fight for the justice you deserve.