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 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.
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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)
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