By Ben Hirschler
LONDON (Reuters) - Last year turned out to be a disappointing one for new drug approvals with the U.S. Food and Drug Administration clearing just 22 new medicines for sale, the lowest number since 2010 and sharply down on 2015's tally of 45.
Across the Atlantic, the European Medicines Agency recommended 81 new prescription products against a 2015 total of 93. Unlike the FDA, the EMA includes generic drugs in its list.
The slowdown suggests the pharmaceuticals industry may be returning to more normal productivity levels after a spike in approvals in 2014 and 2015, when the haul of new drugs reaching the market hit a 19-year high.
Several factors led to the fall in the approval rate in 2016, John Jenkins, the FDA's director of the office of new drugs, told a conference last month.
Notably, five new drugs that had been scheduled for approval in 2016 ended up winning an early green light at the end of 2015. There was also a decline in drugs being filed for approval and the FDA rejected or delayed more applications in 2016 than in the previous two years.
Some of the delayed drugs may yet go on to win approval in 2017, including Roche's multiple sclerosis treatment Ocrevus and Sanofi and Regeneron's sarilumab for rheumatoid arthritis.
Most industry executives remain upbeat about the hunt for new medicines, given recent advances in fighting cancer and an improved understanding of the genetic basis of other diseases, which has resulted in full development pipelines at many firms.
But it remains challenging to get new drugs through the approval process and to secure a decent financial return once they are launched, given resistance from healthcare insurers and governments to the rising cost of medical treatment.
According to consultancy Deloitte, returns on research and development investment at the top 12 pharmaceutical companies fell to just 3.7 percent in 2016 from a high of 10.1 percent in 2010.
Increasing political pressure over the high prices of many modern medicines is a growing challenge at a time when biotech and pharma companies are developing more drugs targeted at niche patient populations.
The issue is exemplified by the last drug to win FDA approval in 2016. Spinraza, from Biogen and Ionis Pharmaceuticals, is the first medicine to treat patients with spinal muscular atrophy, a rare and often fatal genetic disease. It comes at a huge cost of $125,000 per dose.
That price, implying a total cost of $625,000 to $750,000 for patients in the first year and $375,000 in subsequent years, is likely to invite "a storm of criticism, up to and including Presidential tweets", according to Leerink analysts.
President-elect Donald Trump has vowed to bring down drug prices.
For a graphic on U.S. FDA drug approvals, click: http://fingfx.thomsonreuters.com/gfx/rngs/USA-DRUGS/01M0110L20G/USA-DRUGS-01.jpg
(Editing by Louise Heavens)