EMA backs dexamethasone for COVID-19, seven new medicines and consults on ICH Q3D guideline

Regulatory NewsRegulatory News | 21 September 2020 |  By 

The European Medicines Agency’s (EMA) on Friday recommended seven medicines for marketing authorization and began a public consultation on the International Council for Harmonisation’s (ICH) Q3D(R2) guideline on elemental impurities.
EMA also endorsed the use of dexamethasone to treat coronavirus disease (COVID-19) patients who are on oxygen or mechanical ventilation based on results from the RECOVERY trial.
“Published data from the RECOVERY study show that, in patients on invasive mechanical ventilation, 29% of those treated with dexamethasone died within 28 days of starting dexamethasone treatment compared with 41% of patients receiving usual care, with a relative reduction of about 35%. In patients receiving oxygen without mechanical ventilation, the figures were 23% with dexamethasone and 26% with usual care, with a relative reduction of about 20%,” EMA writes, noting that there was no reduction in risk of death observed in patients who were not on oxygen or mechanical ventilation.
The other newly recommended medicines include two vaccines, Sanofi Pasteur’s MenQuadfi (meningococcal group A, C, W and Y conjugate vaccine) and Supemtek (quadrivalent influenza vaccine, recombinant), and a recommendation for Pacira Ireland’s post-operative pain treatment Exparel (bupivacaine).
EMA also recommended SFL Regulatory Services’ anthrax post-exposure prophylaxis drug Obiltoxaximab for marketing authorization under exceptional circumstances. Recommendations were given for Pfizer’s pegfilgrastim biosimilar Nyvepria, Accord Healthcare’s generic version of rivaroxaban and ADIENNE Srl SU’s hybrid medicine Phelinun (melphalan).
EMA says that CHMP will also reexamine its negative opinions for Stemline Therapeutics’ Elzonris (tagraxofusp) and Swedish Orphan Biovitrum’s Gamifant (emapalumab) at the applicants’ request. The committee adopted negative opinions on both products during its July 2020 meeting.
Additionally, EMA has recommended 15 extensions of therapeutic indication, one each for Olumiant (baricitinib), Orfadin (nitisinone), Velphoro (mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches), Deltyba (delamanid), Flucelvax Tetra (influenza vaccine), Fycompa (perampanel), Lynparza (olaparib), Opdivo (nivolumab), Symkevi (tezacaftor/ivacaftor), Tecentriq (atezolizumab), Yervoy (ipilimumab), Zavicefta, Zejula (niraparib) and two extensions for Kalydeco (ivacaftor).
EMA also began a three-month public consultation on ICH’s Q3D(R2) guideline on elemental impurities which recently reached Step 2b of the ICH process. The ICH Q3D(R2) document is part of a maintenance procedure for the elemental impurities guideline being undertaken to provide permitted daily exposure (PDE) levels for elemental impurities for medicines administered via cutaneous and transdermal routes.
EMA, ICH guideline Q3D (R2) on elemental impurities


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