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AbbVie’s approval delay raises further concerns about JAK drugs

Dive Brief:

  • The Food and Drug Administration may take up to three months longer to review an application from AbbVie to get Rinvoq, its marketed medicine for rheumatoid arthritis, also approved to treat active psoriatic arthritis. The company now expects a decision toward the end of the second quarter.


  • AbbVie gave few details about the reasons for the delay in a Wednesday statement, noting only that the FDA had requested new information on the drug’s benefits and risks in psoriatic arthritis patients. But after speaking with the company, Vamil Divan, an analyst at Mizuho Securities, learned the requests were for long-term safety data similar to what Pfizer recently showed for Xeljanz, a rival drug that works like Rinvoq.


  • In January, a large safety study found patients given Xeljanz had a higher rate of health issues like major heart complications and cancer than those who got a different kind of anti-inflammation medicine. According to Divan, the FDA is now looking for more data to better evaluate Rinvoq’s merits in each disease AbbVie is seeking approval — with a specific focus on data against an active comparator.


Dive Insight:

For years, AbbVie’s business has relied on the success of Humira, an anti-inflammatory agent that’s received more than a dozen FDA approvals.

Humira has long been the world’s best selling drug, due in no small part to the wall of patent protection AbbVie build around it. In 2020, of the company’s $45 billion in net product revenue, almost $20 billion came from Humira. The drug’s legacy does have an end date, though, as AbbVie made agreements with generic manufacturers to allow copycat versions to enter the market in 2023.

With its main product in danger, AbbVie has been trying to quickly develop new streams of revenue. Last year, for example, it took control of a lucrative medical aesthetics business through the $63 billion acquisition of Botox-maker Allergan.

AbbVie also views Rinvoq and another inflammation medicine called Skyrizi as important to the company’s post-Humira future. Both received their first approval in 2019, with Rinvoq cleared for rheumatoid arthritis and Skyrizi for plaque psoriasis. Net revenue from the drugs reached $731 million and $1.6 billion, respectively, in 2020.

AbbVie is now focused on expanding the Rinvoq brand. Last year, it asked the FDA to approve the drug as a treatment for psoriatic arthritis, eczema, and a type of spinal arthritis known as ankylosing spondylitis. The FDA will make decisions on AbbVie’s applications throughout this year.

The psoriatic arthritis application, submitted in June, was likely the first to get an FDA verdict. Yet, the agency’s request for more information could cause its review to take three more months.

In addition to the psoriatic arthritis update, AbbVie said it had received a similar request from the FDA related to its eczema application. The company is preparing that information and plans to give it to regulators soon. Abbvie expects a similar delay in eczema, meaning an approval decision may not come until July, according to Mizuho’s Divan.

Investors often have an unfavorable view of delayed review timelines, and AbbVie’s were no exception. The company’s share price dropped 5% Wednesday and fell further Thursday morning, to trade at about $104.

To analysts, the FDA’s response is somewhat expected, and affirms the continued scrutiny of drugs like Rinvoq, Xeljanz and Eli Lilly’s Olumiant, which each block a certain kind of enzyme that’s known to spur inflammation and represent oral alternatives to infusible drugs like Humira.

While effective in multiple autoimmune diseases, these so-called JAK inhibitors have raised safety concerns, specifically their potential to cause serious infection, blood clots and, as Pfizer’s study just found, a higher incidence of heart complications and cancer. Each drug comes with a safety warning on its prescribing information.

“This is another example of what is clearly a new regulatory approach from the FDA – every potentially questionable or uncertain approval event seems to be pushed out, or re-evaluated,” wrote Geoffrey Porges, an analyst at SVB Leerink, in a note to investors Wednesday.

Divan noted that AbbVie’s clinical program has already generated the data the FDA is requesting, so the company won’t have to run additional trials. Overall, the company remains “very comfortable with Rinvoq’s profile and outlook,” and still forecasts approximately $1.7 billion in global Rinvoq sales for 2021, according to Divan.