EMA’s CHMP Recommends First Ebola Vaccine, 6 Other Medicines

Regulatory NewsRegulatory News | 18 October 2019 |  By 

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced recommendations for seven new medicines for approval, including a conditional marketing authorization for Merck’s Ebola vaccine Ervebo (rVSVΔG-ZEBOV-GP, live), which is the first vaccine for those 18 years and older at risk of infection with the Ebola virus.

EMA said that preliminary data suggest the vaccine is effective in the current Ebola outbreak in the Democratic Republic of Congo (DRC). “Additional efficacy and safety data are being collected through the Expanded Access Protocol and should be included in post-marketing safety reports, which are continuously reviewed by EMA,” the agency said.

Tedros Adhanom Ghebreyesus, WHO Director-General, also praised the announcement from CHMP, calling it “a triumph for public health, and a testimony to the unprecedented collaboration between scores of experts worldwide.”

WHO also said there are eight vaccines currently undergoing clinical evaluation. And according to WHO, in the current outbreak in the DRC, there are more than 236,000 people who have been vaccinated with the Merck vaccine donated to WHO, including more than 60,000 health and frontline workers in the DRC, Uganda, South Sudan, Rwanda and Burundi.

Ervebo received a positive opinion for a conditional marketing authorisation from CHMP because “further information related to the manufacturing process can only be submitted in the coming months. This was considered appropriate in light of the ongoing public health emergency in DRC,” EMA said.

A decision by the US Food and Drug Administration (FDA) on the vaccine is due by 14 March 2020.

Impurity Investigation

In addition to Ervebo, CHMP also updated its question and answer (Q&A) document on the agency’s investigation into the potential sources of nitrosamine impurities, which has led to recalls of some blood pressure medicines.

A list of potential sources included the use of contaminated raw materials in the active pharmaceutical ingredient (API) manufacturing process, the use of contaminated starting materials and intermediates supplied by vendors that use processes or raw materials which may allow nitrosamine formation, or the use of cross-contamination due to different processes run on the same line and due to operator-related errors such as inadequate phase separations.

But EMA also said that because there are a substantial number of APIs and finished products involved, “long-term acceptable limits of nitrosamines for non-sartan products are still under consideration.”

The regulator recommended that risk evaluations for all products should be concluded at the latest within six months of the publication of this notification, which was issued 9 October.

“Confirmatory testing activities should start as soon as the risk of presence of nitrosamine is identified from the risk evaluation exercise and should begin immediately for products considered at high risk. Confirmatory testing of all concerned medicinal products and submission of required changes in the manufacturing authorisations should be concluded at the latest within 3 years of the publication of this notification or at an earlier time if otherwise justified,” EMA added.

Other Approvals, Rejections

CHMP also recommended granting a marketing authorisation for Eli Lilly’s Baqsimi (glucagon), which is the first treatment for severe hypoglycaemia (low blood sugar) that can be administered without an injection in patients with diabetes aged 4 years and older. The drug was approved by FDA in July.

Melinta Therapeutics’ Quofenix (delafloxacin) also received a positive opinion from CHMP for the treatment of acute bacterial skin and skin structure infections in adults when it is considered inappropriate to use other antibacterial agents. Known as Baxdela in the US, it was approved by FDA in 2017.

CHMP also recommended granting a marketing authorisation for AbbVie’s Rinvoq (upadacitinib) for the treatment of rheumatoid arthritis. It was approved by FDA in August. Janssen’s Spravato (esketamine) also received a positive opinion for combination treatment in adults with treatment-resistant major depressive disorder. Spravato won approval in the US in March.

Mundipharma also earned a positive opinion for a pegfilgrastim biosimilar intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.

Meanwhile, CHMP recommended the refusal of the marketing authorization for D&A Pharma’s Hopveus, a medicine intended for the treatment of alcohol dependence.

In making its decision, EMA said: “Although some of the studies presented suggested the medicine could be effective in treatment, this was not conclusively demonstrated, and the Agency was concerned because there were several drawbacks in the design and analysis of these studies that could have affected the results. The Agency was therefore unable to confirm that the medicine was effective. In addition the Agency had concerns regarding the misuse and abuse potential of the medicine.”

Daiichi Sankyo’s Vanflyta (quizartinib), a medicine intended for the treatment of adults with acute myeloid leukemia, also received a negative opinion from CHMP.

“Although the results from the main study indicated a marginal improvement in overall survival for patients given Vanflyta, the study had important limitations which meant that the effectiveness of Vanflyta could not be sufficiently demonstrated,” EMA said.

The treatment was denied approval by FDA in June but also approved in June by Japanese regulators.

CHMP Meeting 14-17 October


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