EU regulators back Lilly’s blockbuster RA pill

Lilly may have suffered a major disappointment after the failure of its solanezumab Alzheimer’s drug, but the company is finishing 2016 on a high note after European regulators recommended its key oral rheumatoid arthritis treatment.

Peak sales of baricitinib – brand name Olumiant – are expected to be in the region of $2 billion, as clinical data suggest it is more effective in RA than AbbVie’s big selling injected drug Humira (adalimumab), and in a more convenient pill form.

Olumiant, developed in partnership with US biotech Incyte, is one of a crop of new drugs that Lilly’s new CEO, David Ricks, hopes will turn the company’s fortunes following a difficult few years when several key drugs went off-patent.

Lilly also hopes to steal sales from Sanofi in the insulin market, after launch of a near-copy of the French firm’s big-selling Lantus (insulin glargine) in the US last week.

Lilly has beaten Pfizer to the EU rheumatoid arthritis market with olumiant, a Janus kinase inhibitor, as the European Medicines Agency’s CHMP scientific committee rejected rival Xeljanz (tofacitinib) on safety grounds three years ago.

Pfizer re-filed Xeljanz in Europe earlier this year with fresh data designed to assuage concerns about increased risk of infections related to its immunosuppressant action.

Although approved in the US, the safety concerns have held back Xeljanz – in 2015 total US sales were $470 million, which is solid but considered a disappointment when compared with the multi-billion dollar sales associated with injected RA drugs.

The EMA said Olumiant should be used in patients who have not responded to, or are unable to tolerate, one or more disease-modifying anti-rheumatic drugs (DMARDs). It can be used on its own or in combination with methotrexate.

More than half of patients fail to respond to DMARDs and new treatment options are needed, the EMA said.

Janus kinases enzymes play an important role in the process of immunity and inflammation that occurs in rheumatoid arthritis. By blocking these enzymes, Olumiant is expected to reduce the inflammation and other symptoms of the disease.

It would be first JAK inhibitor to be used in the treatment of rheumatoid arthritis in the EU and offers a different mode of action to what is currently available.

The positive opinion on olumiant from the CHMP will now be passed to the European Commission, which will likely grant a licence in the next few months.

In the US, the FDA is set to make a decision on baricitinib before 19 January.

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