EMA publishes highlights from medicines approved in 2018

14/01/2019 Senza categoria 768 Views
EMA publishes highlights from medicines approved in 2018

The European Medicines Agency (EMA) has recently published an overview of its key recommendations of 2018 on the authorization and monitoring of medicines for human use. In 2018 alone, EMA recommended the marketing authorization for 84 medicines. Of these, 42 present a new substance active that has never been used in the EU before.

There were 5 negative opinions (EnCyzix, Dexxience, Eladynos, Alsitek and Exondys) and 10 withdrawal processes. Amongst the authorized medicines, many of them represent a significant improvement in their therapeutic areas; they include medicines for children, for rare diseases and advanced therapies – some of the most complex areas of innovation given the reduced data available for clinical trials.

In 2018, EMA gave new safety advice to manage risks observed with a number of medicines on the market in the EU. Regulatory measures ranged from a change to the product information to the suspension or withdrawal of a medicine such as:

• Removal from the market of the multiple sclerosis treatments containing daclizumab (Zinbryta and Zenapax) due to serious and sometimes fatal cases of autoimmune encephalitis.

• Recommendation to suspend some quinolone and fluoroquinolone antibiotics and introduce changes including restrictions on the use of all others following a review of disabling and potentially permanent side effects reported with these medicines.

• Recommendation of new measures to avoid exposure of babies to valproate medicines in the womb, because exposed babies are at high risk of malformations and developmental problems.

• Recommendation to restrict the use of retinoid medicines during pregnancy. The review confirmed that all oral retinoids can harm the unborn child.

• Recommendation of new measures to minimise the risk of rare but serious liver injury with Esmya (ulipristal acetate), for the treatment of moderate to severe symptoms of uterine fibroids.

• New recommendation to restrict the use of Keytruda (pembrolizumab) and Tecentriq (atezolizumab) as first line-treatments for urothelial cancer (cancer of the bladder and urinary tract) in some patients with low levels of the protein PD-L1.

• Recommendation to restrict the use of Xofigo (radium-223 dichloride) to patients who have had two previous treatments for metastatic prostate cancer or who cannot receive other treatments, in view of the risk of early death and fractures in some patients.

• Warnings for the HIV treatment dolutegravir (Tivicay) about the possible risk of neural tube defects following exposure in very early pregnancy.

• Warnings for fluoroquinolones antibiotics about the rare risk of aortic aneurysm and dissection.

 • Warning to healthcare professionals that sildenafil (Revatio, Viagra) is associated with an increased risk of pulmonary hypertension & death in infants exposed in utero in a clinical trial in growth retardation (off label).

• Warning to healthcare professionals that rivaroxaban (Xarelto) is associated with an increased mortality, bleeding and clots in patients treated in a clinical trial for trans-catheter aortic valve replacement (off label).

• Recommendation of new risk minimisation measures for hydroxyethyl starch (HES) solutions to protect patients at risk. Measures include training, controlled access and warning on the packaging.

•Recommendation to harmonise the maximum daily dose of the painkiller metamizole and the contraindications to its use in pregnancy or women who are breastfeeding. Marketed in many EU Member States, this medicine may occasionally cause severe side effects, such as effects on the blood.

Omega-3 fatty acid medicines are not effective in preventing further heart and blood vessels problems in patients who have had a heart attack and will no longer be authorised for such use.

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