The Rise in New Drug Approvals in 2011

Pharma IQ
Posted: 08/18/2011

This year has already seen the number of new drugs approved by the United States Food and Drug Administration (FDA) match the total number approved in 2010.

A new report compiled by Burrill & Company reveals AstraZeneca's blood-thinner Brilinta, approved in July, was the 21st to be given the go ahead by the FDA in 2011, putting the total in the first seven months of this year on par with that for the entirety of 2010.

The development comes in the face of falling new drug approvals in recent years, not just in the United States but also in Europe.

Figures from the European Medicines Agency show there were 17 positive opinions in 2009, compared to 51 in 2010.

Although the full list for 2011 is not yet available, there had been 38 positive indications in the year leading up to June, suggesting the total number for 2011 is likely to end up slightly on 2010's figures.

This year has also seen the EMA issue more negative indications than during the whole of 2010, at four compared to last year's two.

However, this slight increase goes little way to reversing the slump which has been seen in recent years. According to G Steven Burrill, chief executive officer of Burrill & Company, the problems which led to this decline are yet to be addressed.

"The industry has to reverse a long-term decline in R&D productivity. And the FDA has to find a way to ensure the safety of new drugs while not slowing the introduction of new and needed therapies or creating undue burdens for developers," he said.

Looking deeper into the figures, the report found a third of those approved this year had not passed the FDA's scrutiny during the first attempt, compared to one in five approved during 2010.

But as Burrill acknowledges, it is too early to call what is being seen a definitive trend.

"Seven months of data is not enough to suggest a significant change in approach at the FDA or that strategies to alter the drug development process to improve productivity are paying off. It is encouraging.

"But improving the pace at which new drugs reach the public will require much more work, both at the agency and in industry."

A second recently-released piece of research has also offered some hope that the situation is improving for those hoping to take a new drug to market in the United States.

Published in Health Affairs, the study from the Friends of Cancer Research revealed approval rates for oncology drugs are higher in the United States than in Europe.

In the period between 2003 and 2010, the FDA approved 36 new cancer drugs, compared to EMA's 26.

The FDA also approved the drugs significantly more quickly, with the 23 that both approved taking an average of 182 days in the United States to 350 days in Europe, which may or may not have contributed to a greater number of applications being received by the FDA.

Of the drugs approved this year, one notable example includes Bristol-Myers Squibb's Yervoy, the first new melanoma drug in 13 years and the first which can extend the life of patients in the late stage of the disease.

More than 12 new drugs are also scheduled to be reviewed before the year end, including another oncology drug, Seattle Genetics' Adcetris, "a first-in-class cancer drug that uses an antibody to target cancer cells with a cytotoxic payload".

Much has been made about the era of blockbuster drugs being over, and this is likely to be a catalyst for much of the new R&D investment.

The emergence of the first Melanoma drug in 13 years and the first Lupus drug in 50 years, Benlysta from Human Genome Sciences, would seem to add weight to the argument that companies are looking towards underserved areas for future development.

This is likely to lead to further applications for new drugs in the years ahead and the rise in approvals seen this year also comes during a particularly strong time for the biopharmaceuticals industry.

However, only time will tell if this short-term increase in new drug approvals forms part of a long-term trend.

Pharma IQ
Posted: 08/18/2011

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