US-only approvals highlight pain points in Europe

The European drug regulator has sometimes been perceived as a soft touch compared with the US FDA – and, although this is no longer the case, some products still seem to find it easier to get the go-ahead in Europe. However, the reverse is also true, with a number of drugs receiving approval in the US well before getting the green light across the pond (see table below).

Diabetes therapies have a reasonably smooth regulatory path in Europe, but the FDA is strict about the data it requires for approval, wanting companies to show a cardiovascular outcomes benefit. Pain drugs face higher hurdles in Europe, but the FDA is desperate for new options against the backdrop of growing opioid addiction in the US – illustrated by the approval of Pacira’s Exparel in the US, but not yet in the EU.

Overall, more products are currently approved only in the US than are approved in the EU alone – 110 and 80, respectively, according to EvaluatePharma (Defitelio highlights a regulatory fault line, March 31, 2016). This makes sense when considering that there are more US-based pharma and biotech companies, which are likely to seek approval in their home market first.

Cost control

Economic factors have a big impact too. Development of the meningitis vaccines Menactra and Trumenba was likely held back in Europe by tighter control over healthcare spending – there have been some questions over whether it is economically viable to vaccinate people against diseases that, while serious, are relatively rare.

Sanofi appears to have abandoned its tetravalent vaccine Menactra; this was the first of its kind in the US, but has since been overtaken by GlaxoSmithKline’s Menveo and Nimenrix, both of which are already marketed in Europe.

Meanwhile, Pfizer is persevering with its vaccine for the most common strain of the virus, meningitis B. if approved in Europe, Trumenba will go up against Glaxo’s Bexsero, which was launched in 2013.

Top 10 drugs available in the US but not Europe
Global sales ($m)
Drug Company FDA approval Approval time (months) Europe phase 2015 2022e
Ninlaro Takeda Nov 2015 4.4 Filed 25 2,506
Darzalex Johnson & Johnson Nov 2015 4.3 Filed - 2,099
Glyxambi Boehringer Ingelheim Jan 2015 12.0 Filed 23 1,779
Uptravi Actelion Dec 2015 12.0 Filed - 1,728
Rexulti Otsuka July 2015 12.0 Phase III 38 1,674
Restasis Allergan Dec 2002 45.9 Phase III 1,048 1,478
Exparel Pacira Pharmaceuticals Oct 2011 13.0 Phase III 240 1,150
Menactra Sanofi Jan 2005 12.9 Abandoned – phase II 681 940
Jublia Valeant June 2014 22.4 Phase III 338 866
Trumenba Pfizer Oct 2014 4.4 Phase III 37 767

Valeant’s toenail fungus treatment Jublia is another example of a drug that can perform well in the US, where direct-to-consumer advertising plays its part, but would probably struggle in the more cost-conscious EU.

The drug, which hit the headlines this year after a costly Super Bowl ad slot, seems a perfect example of the company’s much-maligned pricing strategy – it costs $444 per bottle, according to EvaluatePharma’s sales, volume and pricing module.

European healthcare systems are unlikely to shell out that much for what is essentially a cosmetic problem. But this should soon be put to the test, with European phase III trials ongoing and approval there expected in 2017.

This ability to command higher prices, as well as the sheer size of the market, probably explains why more of the US-only approved drugs are forecast to achieve blockbuster status: seven are set to break the billion dollar barrier by 2022, versus just two of those that currently only have the go-ahead in the EU.

However, changes are afoot in the US, with pricing coming increasingly under the spotlight and new initiatives like risk sharing being implemented (Vantage point – Turning point in the pharma-payer pricing struggle, April 25, 2016). 

If these developments eventually put US and EU drug pricing on an equal footing the differences in the types of drugs approved in each market could begin to disappear.

To contact the writers of this story email Madeleine Armstrong or Edwin Elmhirst in London at or follow @medtech_ma or @EPVantage on Twitter

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