EMA approvals up, rejections down in 2018

By Ben Hargreaves contact

- Last updated on GMT

Related tags: European medicines agency, Novartis, Gilead, Yescarta, Kymriah, Luxturna

The EMA has provided its 2018 overview, which highlighted 84 positive opinions provided and five negative opinions.

In a busy year for the European Medicines Agency (EMA), with its relocation on the horizon​, it approved more new active substances compared with the preceding four years.

The agency totalled 84 positive opinions, which included the approvals of 42 new active substance.

It also oversaw fewer applications failing to make the grade in 2018 compared with the previous year, with five negative opinions and 10 withdrawn applications.

Therapeutics

The therapeutic area with the most approvals was oncology. The approvals​ of Novartis’ Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel) were particularly significant – bringing chimeric antigen receptor (CAR)-T therapies to patients with leukaemia.

The agency also called attention to the approval of Luxturna​ (voretigene neparvovec-rzyl), a gene therapy for the treatment of inherited retinal dystrophy.

Safety

The EMA used its year overview to also provide an update on the work it is doing to ensure a safe supply of medicine to European citizens.

One of the major manufacturing issues of 2018 was discovered by the EMA, after certain ‘sartan’ products were found to be contaminated by probable carcinogens​.

In an update on the scare, the agency noted: “The ongoing review is evaluating the root cause for the presence of these impurities, their possible impact on patients and what measures can be taken to reduce or eliminate these impurities from future batches.”

Relocation

The challenge facing the agency in 2019 will be transferring to its new location in Amsterdam, the Netherlands.

In its latest statement, the agency noted that it would be temporarily suspending or reducing some activities as it enters the third phase of its Brexit preparedness business continuity plan.

However, it stated: “All core activities related to the evaluation and supervision of medicines [will] continue uninterrupted.”

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