Nineteen centrally authorised human medicinal products were considered “at risk” for supply problems to the EU.

The European Medical Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended eight medicines for approval at its February meeting; the last in its London headquarters before the agency moves to Amsterdam as a result of Brexit.

Three of the medicines were granted conditional marketing authorisation, meaning the manufacturer must provide comprehensive clinical data related to the product in the future.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

These are Portola Netherlands’ Ondexxya (andexanet alfa), an antidote for adult patients taking anticoagulants apixaban or rivaroxaban, Akcea Therapeutics’ Waylivra (volanesorsen), the first medicine to treat rare genetic disorder chylomicronaemia syndrome. As well as Pfizer’s Lorviqua (lorlatinib) indicated for anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (NSCLC).

Three products were granted a positive opinion by the CHMP, a crucial step towards final marketing authorisation by the European Commission. The products are BioMarin’s Palynziq for patients aged 16 and above with rare, inherited metabolic disease phenylketonuria, as well as Zynquista (sotagliflozin), an adjunct to insulin for certain type 1 diabetes patients, and Skyrizi (risankizumab) indicated for psoriasis.

The remaining two medicines recommended were GlaxoSmithKline’s Dectova (zanamivir), which was granted marketing authorisation in exceptional circumstances for complicated influenza, and Teva’s generic Pazenir (paclitaxel) indicated for metastatic breast cancer and NSCLC.

The CHMP also recommended an extension of therapeutic indication for five drugs, including Sanofi’s Dupixent as an add-on maintenance treatment for patients 12 years and older with rare forms of asthma.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

AstraZeneca’s Lynparza, Chiesi Farmaceutici’s Riarify and Trydonis, as well as Gilead’s Viread, also saw indication extensions. Breast cancer was added to Lynparza’s indications, Riarify and Trydonis can now treat a larger chronic obstructive pulmonary disorder patient group, and hepatitis B was added to Viread’s indications.

CTI Life Sciences withdrew its application for marketing authorisation for Epjevy (pacritinib citrate) to treat symptoms of myelofibrosis in patients with thrombocytopenia. The EMA said that before the withdrawal, the CHMP had some concerns about the effectiveness of the drug and it could not have been approved for this indication.

The company withdrew Epjevy on the basis it could not generate additional data required to support a successfully CHMP opinion in the required timeframe.