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EMA sees approval numbers rise in 2018

Agency faces Brexit test in 2019


The European Medicine Agency has revealed a final tally of 84 positive opinions on new medicines in 2018, with 42 of these being new active substances.

This number is slightly down from 94 in 2017 however, but the number of new active substances approved in 2018 grew from 35 to 42.

From these, 21 were orphan medicines (exactly 50%) and three were advanced therapy medicinal products – Novartis’ Kymriah and Gilead/Kite’s Yescarta CAR-T therapies, plus Spark’s Luxturna, co-marketed with Novartis.

Unsurprisingly, cancer drugs were the biggest therapy area in the 2018 roll call, with the regulatory body approving 23 in total, including AstraZeneca’s Imfinzi and Takeda’s Alunbrig.

The figures nevertheless show the EMA is still lagging significantly behind the FDA, the US drug regulator reaching a record-breaking tally of 59 new molecular entities for the year.

The FDA’s faster approval rate is based on its sustained efforts to identify promising innovative drugs earlier, and work more closely with developers, via pathways such as the FDA Breakthrough Therapy Designation.

The EMA has made similar moves in recent years with its own ‘accelerated assessment’ routes for priority innovations, such as the Priority Medicines scheme (PRIME), which hits its third year in operation in 2019.

Four medicines gained approval in 2018 following accelerated assessment, which aims to bring down approvals to within 150 days rather than 210 days. These were Roche’s Hemlibra, Shire’s Takhzyro, Alnylam’s Onpattro and Tegsedi.

US shutdown and Brexit

As 2019 begins, both the EMA and the FDA have got major headaches which could delay their drug approvals this year: The FDA is currently without long-term funding because of the US government shutdown, resulting from President Trump’s demands for money to build a border wall being blocked by Congress.

The EMA is also in the midst of the huge undertaking of relocating from London to Amsterdam, because of the UK’s exit from the EU.

The greatest risk to the EMA’s business continuity is staff leaving the agency rather than relocate with it to the Netherlands, though it recently said projections that departures have not reached the 30% level once feared.

Nevertheless, the EMA must also oversee other major transition arrangements resulting from Brexit, including switching away from working with the UK’s MHRA to EU27 agencies, and also helping the industry to plan for licensing and regulatory updates, including the impact of a potential no deal Brexit.

Lastly, the EMA’s key human medicines committee, the CHMP, has a new chairman. Harald Enzmann took over from Dr Tomas Salmonson in September, and has pledged to continue the EMA's evolution in its regulatory approach in response to the rapidly changing nature of medicines.

9th January 2019

From: Marketing



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