AbbVie's Orilissa gets FDA nod as Humira competition looms

AbbVie needs new drugs as its mega-blockbuster Humira won’t bring in billions forever – and after the embarrassing withdrawal of an MS drug earlier this year it has managed to get a substantial sales driver to market with the approval of endometriosis drug Orilissa (elagolix).

The FDA has approved Orilissa for management of moderate to severe pain associated with endometriosis – the first new drug in this indication for more than a decade.

Expected to be available in US retail pharmacies in early August, and the team of analysts at Evaluate Pharma has listed Orilissa as one of the top 10 potential launches in 2018, as measured by predicted sales in 2022.

The drug is also being developed to treat uterine fibroids and according to Evaluate, Orilissa could generate revenues of $1.21 billion in 2022.

Although this is insignificant compared with the $21 billion Humira is expected to generate at its peak, AbbVie is trying to put together a gang of drugs that it hopes will make up the sales when the world’s top-selling drug goes off patent.

Humira is expected to face biosimilar competition in Europe later this year, and in the US in 2023.

Cancer drugs Imbruvica (ibrutinib), and Venclexta (venetoclax) are already on the market through partnerships with Janssen and Roche respectively, as is AbbVie's next-generation hepatitis C combination therapy, Mavyret (glecaprevir+pibrentasvir).

Its psoriasis drug risankizumab is under review with the FDA after strong phase 3 results and could be launched next year if things go well with the regulator.

And AbbVie’s rheumatoid arthritis pill upadacitiniub, also known as ABT-494, has succeeded in several late-stage studies and AbbVie plans filings in the second half of this year.

But it’s not all gone to plan – an antibody drug conjugate called rovalpituzumab tesirine, or Rova-T, threw up some disappointing results in small cell lung cancer in a phase 2 trial earlier this year.

This prompted AbbVie to abandon plans for an accelerated review of the drug, which up to that point had been forecast as a potential $5 billion blockbuster.

There are now serious doubts about the marketability of the Rova-T, as evidenced by the sudden drop in AbbVie’s share price after the trial results were announced.

And although AbbVie managed to get Zinbryta (daclizumab) on the market with partner Biogen for multiple sclerosis, earlier this year the companies withdrew it because of a risk of serious brain inflammation.