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Lilly to pursue industry-first FDA acknowledgment of hair loss due to autoimmune after Olumiant’s second trial victory

Eli Lilly last month trumpeted high-quality results indicating that its rheumatoid arthritis medicine Olumiant can trigger hair regrowth in the autoimmune disorder alopecia areata. However, no drug has ever received an FDA green signal. Based on positive results from a second late-stage study the company now is awaiting approval for a filing on the table.

 

Key Updates:

In a second phase 3 study, a once-daily dose of baricitinib–approved in rheumatoid arthritis as Olumiant–bested placebo at stimulating hair regrowth in patients with severe alopecia areata (AA), Lilly said this week. After obtaining these data, Lilly plans to submit the drug for FDA approval during the second quarter of the year.

After 36 weeks the three-quarters of the patients taking daily baricitinib 4 mg had the minimum of 80% hair growth on their scalp, compared to 22% in the two mg regimen. Just five percent of participants in the placebo group achieved the hair growth target.

The results match with the top-line data of an additional study Lilly released in March. In the study 33% of patients who took the 4 mg dose had the goal of 80% scalp hair cover at the end of week 36, in addition to 17% of those taking 2 mg of baricitinib. Only 3% of the patients who were in the control group met the desired level.

The drug’s efficacy was comparable to baricitinib’s use in rheumatoid and the atopic dermatitis condition, Lilly said. The upper respiratory tract infection, headaches and acne were the most frequent adverse negative effects.

Safety will definitely be a top priority for the FDA as it evaluates Lilly’s request. Baricitinib is part of the JAK inhibitor class of drugs that have been subject to greater scrutiny since an unsatisfactory post-marketing trial for Pfizer’s Xeljanz in the beginning of this year.

After that mishap and subsequent delays, the FDA has decided to delay decisions regarding Olumiant as well as Pfizer’s study of abrocitinib for moderate-to-severe Atopic dermatitis by three years. AbbVie’s Rinvoq is being slammed with two FDA delays, in addition.

However, there’s definitely a need for a regulated A drug and Lilly may be soon having the field all by itself.

“There is a dire need to have approved treatment options for those suffering from alopecia ,” Maryanne Senna, M.D. is a dermatologist who was part of one the trials’ researchers stated in a press release. She said that current topical treatments and steroids available are of no aid to the majority of patients suffering from AA.

Recognizing the requirement to address this need, the FDA last year awarded breakthrough approval to baricitinib AA that may cause small patches of hair loss in the face, scalp and various other parts that are part of our body.

The year 2020 was the one in which Olumiant has generated an estimated $639million across the globe, which is the biggest increase of 50% over the year prior. It is among a variety of brand new drugs Lilly is betting on to boost growth over the next years.

 

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