EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

Regulatory NewsRegulatory News | 16 August 2019 |  By 

The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 to 2016.

In just eight of the 107 applications, FDA initially declined to approve a new drug or biologic while EMA approved it, although in all eight of those cases, FDA ended up approving that drug or biologic. And in one case (Takeda’s Ninlaro (ixazomib) for multiple myeloma), FDA approved the treatment and EMA initially did not, but later did.

“Overall, taking account of the resubmitted and reexamined applications, the EMA and the FDA had final discordant marketing authorization decisions for two drugs: corifollitropin alfa and ataluren,” the study notes, as both were approved by EMA and not FDA.

More recently, however, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted negative opinions for two drugs in 2018 that were approved by FDA in 2017, and one sickle cell drug in 2019 that was also previously approved by FDA. In addition, CHMP raised questions about Mitsubishi Tanabe Pharma’s treatment for amyotrophic lateral sclerosis, which withdrew its application this year, and which was approved by FDA in 2017.

“Divergence in approval decisions, type of approval, and approved indication were primarily due to differences in agencies’ conclusions about efficacy based on review of the same data or differing clinical data submitted to support the application,” the study published in Clinical Pharmacology & Therapeutics found.

In the more recent case of the sickle cell drug, FDA said its approval was based on a trial showing that patients treated with Endari (glutamine) experienced fewer hospital visits for sickle cell crises, on average, when compared to placebo. But EMA’s CHMP said it “considered that the main study did not show that [glutamine] was effective at reducing the number of sickle cell crises or hospital visits.”

The study also notes how FDA more commonly granted accelerated approvals (12/25 in oncology and 5/8 in hematology) than EMA granted conditional marketing authorization or authorization under exceptional circumstances (7/25 in oncology and 2/8 in hematology).

But submissions in these areas often occurred later to EMA than FDA, and often included additional clinical trials or more mature data from the same clinical trial than were submitted to FDA. “In those instances, the EMA was more likely than the FDA to grant standard approval (whereas the FDA issued accelerated approval) or a broader indication,” the study said.

The study also found EMA had a higher rate of first-cycle approvals than FDA, and the researchers “observed remarkable similarity in the basic scientific and data interpretation issues raised by the FDA and the EMA during reviews of the same applications. Specifically, most of the FDA's second cycle approvals (i.e., approvals after resubmission of the applications) were based on submission by the sponsor of the same additional data that EMA had received during its initial review either from the start or following request after clock‐stops.”

In their discussion of the results, the study authors also note the study’s limitations, such as only using two years’ worth of data. But overall, the two agencies are communicating and working together more closely than in years past.

“The high rate of convergence in the authorisation of new medicines at EMA and the FDA is the result of expanded investment in dialogue and cooperation since 2003 and has fostered alignment between the EU and the US with respect to decisions on marketing authorisations, while both agencies evaluate applications independently of each other,” said Zaide Frias, head of EMA’s human medicines evaluation division. 



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Tags: approvals, drugs, EMA, FDA

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