EMA’s Clinical Data Statistics from January 2016 to April 2018

European Medicines Agency's (EMA) clinical data websitecontains clinical reports submitted to the Agency under the following procedures:

  • as part of a centralized marketing authorization application (from 1 January 2015)
  • as part of new indication or line extension applications relating to existing centrally authorized medicinal products (from 1 July 2015)
  • as part of a procedure under Article 58 of Regulation (EC) No 726/20042 (from 1 January 2015)

Data are provided by pharmaceutical companies and assessed by Committee for Human Medicinal Products3.

Clinical data not covered by the EMA’s publication policy4 include:

  • data submitted to the Agency before the established dates
  • data submitted to EMA for non-centrally authorized products
  • data on centrally authorized products that are not held by EMA
  • pharmacovigilance data based on individual case safety reports (ICSRs)

Here we present the statistics of clinical data published from 1 January 2016 to 9 April 2018.

 

The total number of clinical reports was 87. We identified 56 applications for initial marketing authorization, 30 applications for extension of indication, and only 3 for line extensions. The vast majority of products have received approval. Seven applications were withdrawn. We found no clinical reports submitted under Article 58 (medicines for markets outside the EU) and no applications that have been refused a marketing authorization. Eighteen reports were related to generic medicines, 15 were for orphan medicines, and 5 for biosimilars. 

One application was submitted for a conditional marketing authorization. It was an initial marketing authorization request for Pandemic influenza vaccine H5N1 (AstraZeneca AB). Another one application was submitted under ‘exceptional circumstances’. It was related to the orphan medicine for the treatment of a rare autosomal disorder Cerebrotendinous xanthomatosis. Both applications were approved.

Approximately one third of medicinal products were anticancer drugs. Other common drug targets were viral infections (mainly HIV infection), autoimmune diseases, genetic disorders (Duchenne muscular dystrophy, haemophilias, etc.), and diabetes. It is not surprising since a centralized authorization procedure is mandatory for most of these drug types.

Most viewed clinical data in 2017

Product name

Active substance

Target condition

Marketing authorization holder

Zurampic

Lesinurad

hyperuricemia associated with gout

Grunenthal GmbH

Odefsey

Emtricitabine / Rilpivirine / Tenofovir alafenamide

HIV-1 infection

Gilead Sciences International Ltd

Descovy

Emtricitabine / Tenofovir alafenamide

HIV-1 infection

Gilead Sciences International Ltd

Kyprolis

Carfilzomib

multiple myeloma

Amgen Europe B.V.

Zepatier

Elbasvir / Grazoprevir

hepatitis C

Merck Sharp & Dohme Limited

TAGRISSO

Osimertinib

non-small cell lung cancer

AstraZeneca AB

Epclusa

Sofosbuvir / Velpatasvir

hepatitis C

Gilead Sciences International Limited

Praxbind

Idarucizumab

thrombotic events

Boehringer Ingelheim International GmbH

Taltz

Ixekizumab

plaque psoriasis

Eli Lilly Nederland B.V.

Giotrif

Afatinib

non-small cell lung cancer

Boehringer Ingelheim International GmbH

Empliciti

Elotuzumab

multiple myeloma

Bristol-Myers Squibb Pharma EEIG

Zavicefta

Ceftazidime / Avibactam

gram-negative bacterial infections

Pfizer Ireland Pharmaceuticals

Pandemic influenza vaccine H5N1 AstraZeneca

Pandemic influenza vaccine (H5N1) (live attenuated nazal)

influenza

AstraZeneca AB

Lonsurf

Trifluridine / Tipiracil

colorectal cancer

Les Laboratoires Servier

Tarceva

Erlotinib

non-small cell lung cancer

Roche Registration Limited

 

Among the 15 most viewed clinical reports, 13 were submitted as part of the initial marketing authorization, and two reports – as part of new indication applications (for Giotrif® and Tarceva®). All applications were approved. It is noteworthy that the majority of target diseases were serious life-threatening conditions with a significant socio-economic impact.

Notification: although EMA has established timelines for publications, there is currently a delay in publishing clinical data submitted in 2015 and 2016. As of March 2018, EMA is processing applications with Committee for Human Medicinal Products opinions in the fourth quarter of 20165.

 

References

[1] European Medicines Agency clinical data website. Accessed 10 April 2018.
https://clinicaldata.ema.europa.eu/web/cdp/home

[2] Regulation (EU) No 726/2004 of the European Parliament and of the Council. Accessed 10 April 2018.
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2004_726/reg_2004_726_en.pdf

[3] Committee for Medicinal Products for Human Use (CHMP). Accessed 10 April 2018. http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp&mid=WC0b01ac0580028c79

[4] European Medicines Agency policy on publication of clinical data for medicinal products for human use. Accessed 10 April 2018. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf

[5] European Medicines Agency clinical data website. Clinical data available. Accessed 10 April 2018. https://clinicaldata.ema.europa.eu/web/cdp/background

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