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Before 2019 closes, the FDA has 3 key approval decisions to make

The Food and Drug Administration is on an atypical streak of speedy approvals. Over the last few weeks, the agency greenlit medicines from Novartis, Vertex, BeiGene, Alnylam Pharmaceuticals and Global Blood Therapeutics months ahead of schedule, helping to prop up a year that hasn’t seen as many new drugs hit the market as its predecessor.

The year isn’t over, either. A handful of closely watched drug applications remain under review. If approved — or, in one case, approved again — the drugs could bring in millions of dollars for their respective manufacturers.

Analysts expect the FDA will clear these treatments without much pause, but nothing is certain in drugmaking. As demonstrated by the recent string of early approvals, the agency and its regimented review process can still surprise.

Allergan’s ubrogepant — PDUFA set for mid-December

Ubrogepant is part of a new class of migraine drugs that includes Amgen’s Aimovig, Eli Lilly’s Emgality and Teva Pharmaceutical’s Ajovy. While ubrogepant would have the unenviable position of being fourth to market, Allergan argues that its drug holds advantages over the competition.

For one, ubrogepant is meant to treat migraines once they’ve happened, whereas Aimovig, Emgality and Ajovy are for migraine prevention. Allergan’s offering also comes as a tablet rather than an injection, which should help adoption and adherence since patients tend to prefer oral drugs.

With two successful late-stage trials and a long-term safety study backing it, ubrogepant is set up for approval. So too, however, is a rival oral migraine drug from Biohaven Pharmaceuticals. Known as rimegepant, the drug could gain approval for acute migraine in the first quarter of 2020 and for migraine prevention not long after.

Piper Jaffray models $40 million in rimegepant ​sales next year and more than $1 billion by 2024.

Amarin’s Vascepa — PDUFA set for Dec. 28

Amarin’s modified fish oil pill, Vascepa, first cleared regulators’ desks in 2012 for adults with too high triglyceride levels. Revenue from Vascepa has ticked up over the years, reaching $180 million in 2017 and $228 million in 2018.

But Wall Street expects sales to spike if Vascepa gains an additional approval for reducing the risk of cardiovascular events. The FDA should make its decision about a label expansion by late December — and if it’s positive, Jefferies and Stifel both estimate peak sales reaching about $3 billion.

The odds of approval are fairly high. Earlier this month, a committee that advises the FDA voted unanimously in support of Vascepa’s cardiovascular benefits. While the agency isn’t required to follow the committee’s advice, it usually does.

Intra-Cellular’s lumateperone — PDUFA set for Dec. 27

Arguably the most precarious drug left on the FDA’s 2019 docket is lumateperone. Its developer, Intra-Celluar Therapeutics, sees it as a potential therapy for schizophrenia and bipolar depression, two illnesses where drugmakers have had a hard time finding success.

Lumateperone has a troubled track record itself. In early July, Intra-Cellular announced that the drug had failed in a late-stage bipolar study. And just a couple weeks later, the FDA canceled an advisory committee meeting meant to discuss its use in schizophrenia.

Unsurprisingly, the biotech’s share price plummeted on the two setbacks. While it has recovered somewhat, shares are still down about 12% since the start of the year.

Intra-Cellular could mount a rebound on Dec. 27, when the FDA is poised to make a decision for lumateperone in schizophrenia. Sell-side analysts continue to be bullish on the drug’s chances of approval, noting how Intra-Cellular has been ramping up its commercial and manufacturing teams in recent months.

The recent approval of Johnson & Johnson’s Spravato (esketamine) in depression may be a good sign too for lumateperone​, as the drug also had a mixed performance in the clinic.