After an unusually slow year for new drug approvals—the FDA greenlighted just 22 meds in 2016—it remains to be seen whether drugmakers can do much better in 2017. One thing’s for sure, though: No matter what total the industry tallies up this year, the crop will bring some would-be blockbusters and market disrupters.
At the top of the list, according to EP Vantage’s 2017 preview, which ranks the year’s rollouts by 2022 sales, is Ocrevus (ocrelizumab), the Roche multiple sclerosis drug that’s promising to shake things up in more ways than one. In clinical trials, the candidate bested Merck KGaA’s standard therapy Rebif, and it’s also gone where no other MS drug has gone before, posting positive data in patients with the primary progressive form of the disease. Those data will put the heat on other meds—and invite payers to pile pressure onto the segment, too.
Ocrevus isn’t the only new med slated to break into a brand-new market. Analysts think Sanofi and Regeneron hot-shot Dupixent (dupilumab) could make a big splash in severe atopic dermatitis, assuming payers don’t get in the companies’ way. Ditto for Biogen’s Spinraza, which in December became the first FDA-approved product to treat spinal muscular atrophy—but whose high sticker could raise eyebrows at a time when U.S. President Donald Trump is threatening pricing action.
Several of 2017’s launches will mark particularly pivotal points for their companies as their inaugural rollouts. Tesaro is looking for its second-ever FDA approval, while Neurocrine is going after its first, in ovarian cancer pill niraparib and tardive dyskinesia therapy Ingrezza, respectively. And Kite Pharma is aiming to get the first-ever CAR-T cancer drug to market, with a candidate, KTE-C19, that the oncology community will be watching closely as the next big thing in immunotherapies.
Other big 2017 launches won’t necessarily be pioneers in their fields or for their companies, but they could make competitors sweat. Take Novartis’ ribociclib, aka LEE011, which aims to challenge Pfizer’s Ibrance in the CDK 4/6 breast cancer space. Or semaglutide, Novo Nordisk’s weekly GLP-1 drug, a would-be successor to the company’s blockbuster Victoza; the Danish drugmaker boasts some early cardiovascular outcomes data to use in the market-share fight against Eli Lilly’s weekly Trulicity.
And then there are those that have their work cut out for them if they want to crack the industry leaderboard. Eli Lilly’s rheumatoid arthritis remedy baricitinib is hoping to carve out a billion-dollar opportunity in a market where Pfizer’s Xeljanz has faltered. And AstraZeneca’s durvalumab will be weighing into the already-racing immuno-oncology field, to see how many checkpoint inhibitors that market can send to blockbuster land.