It’s a not-so-Good Friday for Eli Lilly and pharma partner Incyte.
Instead of celebrating the approval of a potential blockbuster drug, the two companies are mulling over a complete response letter (CRL) from the U.S. FDA requesting more data on safety and dosing.
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The drug in question is baricitinib (to be sold as Olumiant), a once-daily oral JAK 1/2 inhibitor for moderate-to-severe rheumatoid arthritis (RA). Despite the cluster of therapies now available for RA, EvaluatePharma had projected sales of Olumiant to reach nearly $1.8 billion per year by 2022.
What went wrong? The European Commission gave baricitinib the green light two months ago. U.S. patients could now face a delay of over a year.
Neither pharma company is obliged to share the exact details of the CRL. In a joint statement, they said the FDA had signaled that “additional clinical data are needed to determine the most appropriate doses.” There was also a call for more data “to further characterize safety concerns across treatment arms.”
The unexpected setback will likely cost Lilly and Incyte millions in lost sales, compounded by the long-term nature of RA drugs. When a patient finds a workable regimen, they’re unlikely to switch over.
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“We are disappointed with this action,” stated Christi Shaw, president of Lilly Bio-Medicines in the release. “We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA. We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S.”
Lilly licensed baricitinib and certain “follow on compounds” from Incyte in late-2009 for $90 million upfront, up to $665 million in potential milestone payments and double-digit royalties on sales. With no FDA approval, Incyte will also be feeling the burn.
Rheumatoid arthritis and beyond
Rheumatoid arthritis is a relatively common autoimmune disease, affecting around 1.3 million Americans and many more individuals worldwide. But there’s a positive side. Arguably more than any other disease area, RA medicine has been transformed by the introduction of biologics.
Prior to 1998, just a handful of repurposed drugs were available to help mitigate the disease, including methotrexate, sulfasalazine, and antimalarials. That changed in the early 2000s with the introduction of the TNF-alpha inhibitors Humira, Remicade, and Enbrel. By 2013, all three were ranked among the top ten highest grossing drugs in the world with global revenues of $11.1 billion, $9.9 billion, and $8.9 billion respectively, notes a GBI Research report.
The drugs show efficacy across a range of autoimmune diseases, including psoriasis, Crohn’s disease and other forms of arthritis. That’s the aim for baricitinib too.
Lilly is currently recruiting patients for a Phase 1/2 study of the drug in Chronic graft versus host disease (cGVHD), according to clinicaltrials.gov. A 300-patient Phase 2 trial of baricitinib in systemic lupus erythematosus (SLE or lupus) and another in atopic dermatitis (eczema) are also underway. A Phase 3 study of baricitinib in psoriatic arthritis is expected to kick off later this year.
But time is of the essence, particularly when dealing with the first FDA approval.
Sanofi and Regeneron are trying to win back lost time for their RA drug sarilumab, an interleukin-6 receptor (IL-6R) antibody. They received a CRL in October 2016 for failing a manufacturing inspection.
Johnson & Johnson’s Janssen biotech has also filed its biologics license application for sirukumab, a monoclonal antibody that also works through IL-6.
Photo: Warchi, Getty Images
