The European Medicines Agency (EMA) has published a roundup of its activity in 2019, revealing that last year it recommended a total of 66 human medications for marketing authorisation.
Once this authorisation is granted, these medicines can be made available to patients in any of the EU’s member states. Even after a medication has been approved, the EMA and organisations within individual EU member states continue to monitor its performance and ensure it remains safe for patients to use.
Within the 66 new medications approved for use last year, there were a total of 30 new active substances, which had never been authorised for use in the EU before.
In an infographic, the EMA highlighted some of the new medications that were recommended for approval.
For example, five of the six new cancer medications that received the EMA’s recommendation contain a new active substance. One of these, Vitrakvi, was also singled out by the organisation as providing a particularly important contribution to public health.
Vitrakvi is described as “the first ‘histology-independent’ treatment in the EU for solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion”. The organisation noted that NTRK gene fusions “occur very frequently in a number of rare cancers”.
The other new cancer medications recommended for approval in 2019 are Libtayo, Lorviqua, Pazenir, Talzenna and Vizimpro.
Haematology and hemostaseology was the field of medicine with the greatest number of new drugs approved by the EMA in 2019. In total, 16 new medications in this area were recommended by the organisation, with seven of them containing a new active substance.
Of those, Zyntegio was named as one of the medicines that will have the greatest impact. This product is for the treatment of beta-thalassaemia, a rare inherited blood condition that causes severe anaemia.
Zyntegio has been recommended for “adult and adolescent patients 12 years and older who need regular blood transfusions to manage their disease and have no matching donor for a stem cell transplant”.
In the field of endocrinology, meanwhile, only five new treatments were recommended for use in patients, but two of those were picked out has having a significant impact on public health.
Baqsimi is the first treatment for patients with severe hypoglycaemia that can be administered to patients aged four and older with diabetes without an injection. Zynquista, meanwhile, is described as “an oral adjunct to insulin for certain patients with type 1 diabetes”.
In 2019, three medications were recommended following accelerated assessments. The vaccine Ervebo, which is designed to protect against the Zaire ebola virus was among them.
The other two are medications in the field of haematology – Zyntegio, which is described above, and Xospata. The latter is used to treat adults with acute myeloid leukaemia.
As well as recommending new drugs for use across the EU, the EMA also assesses applications for the use of existing medications to be extended to cover other conditions. In 2019, it made 60 such recommendations.
Among the medications recommended for an extension were Forxiga and its duplicate Edistride, Victoza and Dupixent.
In 2020, the EMA will undergo a series of changes. Firstly, it is moving its headquarters to Amsterdam Zuidas. Like many EU agencies, it is also preparing for Brexit. In addition, there are two important new pieces of legislation that will affect the EMA – one relating to veterinary medicine and the other to medical devices.
A press release following the EMA’s December management board meeting pointed out that the EMA is conducting an “in-depth review of its organisation” to ensure it can continue to meet the needs of the EU and that it’s able to meet future challenges surrounding big data, digitalisation and the introduction of new scientific methods and technologies.
It also released an update on the first phase of its trial of the EU Single Point of Contact (SPOC) network, which was set up last year to help member states better share information about the availability of authorised medicines and any shortages that may be experienced.
The first phase took place between April and August last year when 52 notifications of shortages were shared. In total, 24 EU member states used the SPOC system during the pilot.
Phase two of this project is expected to be launched later this year and will focus on testing additional responsibilities of the SPOCs to improve how shortages of medicines are handled across the EU.
The EMA announced that it will share the results of phase two once this part of the trial has been completed.
It could mean that there is greater demand for pharmaceutical transportation companies to help move medication around the continent to ensure it reaches the patients who need it.