EMA releases 2021 human medicines highlights report

Regulatory NewsRegulatory News
| 21 February 2022 | By Jeff Craven 

The European Medicines Agency (EMA) has released its human medicines highlights report, which features some differences in drugs recommended for marketing authorization compared with approvals from the US Food and Drug Administration (FDA) in 2021.
EMA’s report is not a one-to-one comparison to either the recent FDA Center for Drug Evaluation and Research (CDER) report on drug approvals based on either new drug applications (NDA) or biologics license applications (BLA) or the listing of BLA approvals put out by the Center for Biologics Evaluation and Research (CBER) (RELATED: FDA approved more first-in-class drugs, gave more accelerated approvals in 2021, Regulatory Focus 07 January 2022).
In total, EMA made recommendations for authorization of 53 new active substances compared with FDA’s 50 new drug approvals, which consisted of either new molecular entities (NMEs) or new biologics under Biologics License Applications (BLAs). Medications with a new active substance that were recommended for approval by EMA include the reproductive medicine Ryeqo, the gene therapy Skysona (which was withdrawn), the recombinant human growth hormone (rhGH) Ngenla, the gonadotropin-releasing hormone (GnRH) receptor antagonist Yselty, the dermatology drugs Bimzelx and Cibinqo, and the chronic kidney disease drug Evrenzo.
EMA’s Committee for Medical Products for Human Use (CHMP) issued negative opinions in 2021 for the medicines Aduhelm, Flynpovi, Ipique, Nouryant, and Raylumis.
The European regulator approved two COVID-19 vaccines that have not been granted emergency use authorization (EUA) in the United States, Nuvaxovid (Novavax) and Vaxzevria (AstraZeneca). COVID-19 therapeutics approved in Europe in 2021 include the monoclonal antibody treatments Regkirona, Ronapreve, and Xevudy; the immunosuppressive drugs RoActemra and Kineret; and the antiviral drug Veklury. Of these, only Veklury is approved by the FDA as a COVID-19 treatment, while Ronapreve, Xevudy, RoActemra are being used in the US under emergency use authorizations (EUA).
Both EMA and FDA approved a number of the same medicines in 2021, including cancer medicines (Jemperli, Lumykras, Padcev, Rybrevant, Tepmetko); two COVID-19 vaccines (COVID-19 Vaccine Janssen, Spikevax); cardiovascular medicines (Kerendia and Verquvo); a metabolism medicine (Evkeeza); a reproductive medicine (Lydisilka, also known as Nextstellis in the US); an endocrinology medicine (Lonapegsomatropin Ascendis Pharma, known as Skytrofa in the US); medicines in the immunology, rheumatology, and transplantation categories (Saphnelo, Tavneos, and Voxzogo); hematology medicines (Brukinsa and Oxbryta); and vaccines (Apexxnar [Prevnar 20 in the US] and Vaxneuvance).
Additional medicines EMA recommended for marketing authorization in 2021 had already been approved by FDA in 2020 or earlier.
Seven biosimilars in 2021 were recommended for authorization by EMA: four biosimilars for cancer (Abevmy, Alymsys, Oyavas, and Lextemy, which was withdrawn), two biosimilars in
the Immunology/Rheumatology/Transplantation category (Hukyndra and Libmyris), and one biosimilar in ophthalmology (Byooviz). In contrast, CDER approved Byooviz, but also the interchangeable biosimilars Semglee and Rezvoglar for type 1 and type 2 diabetes, as well as the adalimumab biosimilar Yusimry.
Three medicines were recommended for marketing authorization under accelerated assessments, and thirteen medicines under conditional marketing authorization. In the US, CDER approved 37 drugs through at least at least one expedited pathway, with 34 drugs approved under Priority Review, 18 drugs having Fast Track status, 14 drugs with Breakthrough Therapy status, and 14 drugs under the Accelerated Approval pathway.
EMA and FDA also shared several expedited drug approvals in 2021, including Abecma, Bylvay, COVID-19 Vaccine Janssen, Evkeeza, Evrysdi, Gavreto, Jemperli, Oxbryta, Rybrevant, and Spikevax.
Conditional marketing authorization was granted to seven cancer drugs, one neurology drug, four COVID-19 vaccines, and one hematology drug. Approval under exceptional circumstances was granted to four medicines – Voraxaze (cancer), Bylvay (gastroenterology/hematology), Tecovirimat SIGA (infections), and Evkeeza (metabolism). EMA also recommended six medicines with priority medicine (PRIME) designations receive approval; although Skysona was recommended for marketing authorization, it was later withdrawn.
Human Medicines Highlights 2021


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