- The Food and Drug Administration has pushed back its deadline for reviewing eczema and arthritis drugs from Pfizer and Eli Lilly, casting further doubt on a class of medicines that target a wide range of inflammatory diseases.
- Lilly said Tuesday that the FDA asked for more data analyses on the use of its drug, Olumiant, in moderate to severe eczema. The agency now needs extra time to review the information, meaning an approval verdict might not come until early in the third quarter.
- Meanwhile, Pfizer didn't say why the FDA is delaying reviews for two of its medicines, which both now have an action deadline of the early third quarter as well. The company is looking to get an experimental drug called abrocitinib approved for moderate to severe eczema, while also asking the FDA to clear the already marketed medication Xeljanz for a rare type of arthritis known as ankylosing spondylitis.
The new delays facing Pfizer and Lilly are further proof regulators are concerned about JAK inhibitors, a class of anti-inflammation drugs that includes Xeljanz, Olumiant and AbbVie's Rinvoq.
While JAK drugs have proven effective at fighting a range of diseases — Xeljanz, for one, is approved in the U.S. for ulcerative colitis and three kinds of arthritis — they also come with safety issues. The marketed JAK drugs all contain warnings about their potential to cause serious infection, malignancies and blood clotting events.
Additional flags were raised in January, when results from a large safety study found patients taking Xeljanz had a higher incidence major heart complications and cancer than those who got a different kind of anti-inflammation medicine.
Not long after those results were published, AbbVie disclosed the FDA could take up to three months longer reviewing an application meant to get Rinvoq, which is already used as a rheumatoid arthritis treatment, also approved for active psoriatic arthritis. Now, applications for Olumiant and Xeljanz could take longer to review, too.
Vamil Divan, an analyst with Mizuho Securities, wrote in a note to clients Wednesday that his team wonders whether the FDA may be gearing up to hold a special advisory committee hearing to review the safety of JAK inhibitors. Notably, the agency has appeared increasingly conservative in recent months, issuing a number of review delays as well as a rejection of an Acadia Pharmaceuticals drug that had delivered positive results in clinical testing.
Some analysts fear the new review delays and larger safety issues surrounding JAK inhibitors may hurt the prospects for abrocitinib, a drug that could be important to Pfizer's bottom line. Divan's team, for instance, believes abrocitinib has a 65% chance of approval, down from 80% earlier. They also lowered their sales estimate of the drug in 2030 from just over $1 billion to about $850 million.
Pfizer has envisioned peak yearly sales of abrocitinib reaching $3 billion, according to Divan.
As for the application for Xeljanz's use in ankylosing spondylitis, Divan wrote that it's a "relatively small market opportunity" and therefore less impactful to Pfizer's business.
Lilly, meanwhile, said it remains confident in the potential for Olumiant to treat moderate to severe eczema, and that research of the drug continues in other diseases, including COVID-19. The company said the FDA's decision won't affect its financial guidance for 2021.