FDA gives Lilly’s Olumiant breakthrough status for hair loss

Eli Lilly’s Olumiant is facing tough competition in its approved rheumatoid arthritis indication, but could take the lead in alopecia areata (AA), a common cause of hair loss.

The FDA has granted Lilly a breakthrough designation (BTD) for JAK inhibitor Olumiant (baricitinib) in AA, an autoimmune disease that typically first manifests in childhood and leads to loss of hair in patches on the scalp, face and sometimes other areas of the body. In extreme cases it can lead to loss of all head and body hair.

There are no approved treatments in the US for this type of alopecia, which affects around 6.8 million people in the US alone. At the moment it can only be managed using powerful corticosteroid drugs, which suppress the immune system but can have serious side effects if used long-term.

The BTD for Olumiant – originally developed by Incyte – has been granted on the strength of phase 2 results from an ongoing 725-patient phase 2/3 trial called BRAVE-AA1, which compared 2 mg and 4 mg doses of the drug with placebo in adults with severe or very severe AA.

The phase 3 stage of that trial is now underway along with a second pivotal study (BRAVE-AA2) involving 476 participants. Both are due to generate results before the end of this year, setting up possible filings for Olumiant in AA in 2021 if positive.

Olumiant has been approved as a treatment for rheumatoid arthritis in the US since 2018, getting a first green light in the EU a year earlier, and is now approved for this indication in 65 countries worldwide.

It has failed to live up to its blockbuster potential because it was approved only at a 2 mg dose and with a black box warning on its label for risk of infections, cancer and blood clots.

Lilly has been steadily building a case for the safety of the 4 mg dose – which was more effective in arthritis trials – in the hope of raising its competitive profile against other drugs in the JAK inhibitor class, whilst also developing it for new indications such as atopic dermatitis.

Other JAK inhibitors on the market include Pfizer’s Xeljanz (tofacitinib), which also has a black box warning for infections and cancer, as well as new JAK1-selective inhibitor Rinvoq (upadacitinib) from AbbVie that is billed as having a better safety profile.

Sales of Olumiant seem to be on the rise as confidence builds with the drug – more than doubling last year to $427 million – but it still has a long way to go before it can chase down market-leader Xeljanz with a 2019 turnover of more than $2.2 billion.

Rinvoq meanwhile – which was approved towards the end of the year – brought in $47 million for AbbVie in 2019.