Already 2014 is shaping up to be a year that will see the most new drugs approved by the US FDA for over a decade, but it might come as a surprise to see that, despite the huge strides made by biologicals, small molecules are still holding their own.
Of the 29 additional US launches expected by the end of the year just nine will be biologicals, though this does include two of the top three drugs in order of consensus sales within five years of launch (see table below). Indeed, the revenue estimate analysis shows biologicals commanding the lion’s share of the most lucrative upcoming launches.
Thus the disparity between biologicals and small molecules only begins at the lower end of the list, with the two new drug categories taking an equal share of the top 14 remaining launches of 2014. 25 drugs having already been approved in the US this year, the year’s potential tally could hit 54 (Record US approval run sustains bull market hopes, July 21, 2014).
|US approvals expected by the end of 2014|
|US sales ($m)|
|Pembrolizumab||Yes||Merck & Co||12||1,815|
|V503||Yes||Merck & Co||73||393|
|Orbactiv||No||The Medicines Company||4||295|
|Suvorexant||No||Merck & Co||6||241|
|Elonva||Yes||Merck & Co||15||87|
|Striverdi Respimat||No||Boehringer Ingelheim||–||–|
At least one of the biological launches – that of Bristol-Myers Squibb’s nivolumab – is debatable, and it will take a super-keen FDA to approve it this year. Meanwhile, the top-selling expected small-molecule launches are two combination hepatitis C antivirals and Esbriet, an idiopathic pulmonary fibrosis project that is already sold in Europe.
Esbriet recently secured US breakthrough therapy designation, matching Boehringer Ingelheim’s IPF competitor, nintedanib, which is thought to have a US action date next February. Two other Boehringer projects, the recently resubmitted empagliflozin for diabetes and olodaterol for COPD, could receive quick verdicts now that long-running manufacturing defects have been remedied.
Indeed, this could add clarity to the German group’s COPD combination strategy, within which olodaterol should make a far greater impact than as a standalone drug.
Other small molecules worth watching are idelalisib – Gilead’s foray into oncology, to be pitted against Pharmacyclics’ Imbruvica – and Bristol’s own hep C agent, daclatasvir.
The list of 29 potential approvals is, of course, the result of sellside consensus expectations, some of which are unrealistic.
The dubious category is headed by AstraZeneca’s ovarian cancer project Lynparza, slapped with an 11-2 advisory panel vote against approval in June. Novartis’s anti-IL-17 MAb secukinumab is being pitched at a crowded psoriasis market, and has yet to negotiate an advisory panel review in October.
A decision on Merck & Co’s human papillomavirus vaccine V503, a Gardasil follow-on, could, like the verdict on nivolumab, slip into 2015; the PDUFA date for Cubist’s antibacterial combo of ceftolozane/tazobactam is December 19, while Aeterna Zentaris’s Macrilen has a November 5 action date.
Meanwhile, a six-month priority review for treating Gaucher’s disease put the expected PDUFA date for Sanofi’s Cerdelga at June 11, but so far no news has emerged about a decision. Sanofi told EP Vantage that it had not disclosed an action date, but expected a decision in the third quarter.
FDA action dates are clearly subject to change in both directions, but at this stage nothing can detract from the fact that 2014 should be a memorable year for US approvals of biologicals and small molecules alike.