New drug approvals fall to six-year low
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[January 02, 2017]
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.
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A person holds pharmaceutical tablets and capsules in this picture
illustration taken in Ljubljana September 18, 2013. REUTERS/Srdjan
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
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
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.
(Editing by Louise Heavens)
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