Europe slower than US to approve new cancer drugs
pharmafile | June 17, 2011 | News story | Sales and Marketing | EMA, FDA, FDA approvals, new drug approvals
The European Medicines Agency approves fewer new oncology drugs than its US counterpart and takes nearly twice as long to appraise those it does pass.
That was the conclusion of a new study from the Health Affairs Journal, which found the median time between submission and approval dates was 182 days for the FDA, compared to 350 days for the EMA.
Of the 35 drugs investigated between 2003 and 2010, the FDA approved 32, where the EMA only approved twenty-six, and all of the approved drugs were launched in the US first.
The study by the Friends of Cancer Research charity does note that most drugs were submitted first to the FDA, but it also highlighted a concerted effort at the US regulator to bring them to market more quickly.
The researchers said: “Contrary to repeated public assertions, we found that new oncology medicines are consistently available in the United States before they are in Europe, and they are more likely to be approved by the FDA than by the EMA.”
The researchers noted that there were some limitations with their study, saying that they only looked at the initial drug applications and not any delays developers may have experienced before they filed, but added this was still a good reflection of the differences between the agencies.
The charity also points out that for a drug to gain approval in the EMA it must pass through two steps – to receive a positive opinion from its safety arm the CHMP and then have this affirmed by the European Commission to adopt that positive opinion.
In the US, a new cancer drug must only gain approval from the FDA, after which the drug is ready to be launched, making the process quicker.
Only two cancer drugs – prostate cancer treatment Firmagon and leukaemia drug Treanda – took longer under the FDA to be approved than in the EU, but both still reached the US market before they were approved in Europe.
Novartis’ blood cancer drug Tasigna had the longest time gap, taking just 181 days under the FDA, compared to 568 days under the EMA.
The researchers concluded: “The FDA is often accused of being slow to approve oncology drugs. However, critics have not provided specifics, and our study plainly shows that such assertions are unwarranted.
“The rapid approval of oncology drugs is not accidental, nor is it surprising [as] the FDA has long sought to conduct more rapid reviews of drugs with greater therapeutic potential, particularly anticancer drugs.”
Ben Adams
Related Content
AbbVie’s Tepkinly gains positive CHMP opinion for follicular lymphoma treatment
AbbVie has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human …
GSK’s Jemperli accepted for review by EMA for endometrial cancer treatment
GSK has announced that the European Medicines Agency (EMA) has accepted the application to expand …
FDA approves AbbVie’s Skyrizi for UC treatment
AbbVie has announced that the US Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) …
