Euro Roundup: EMA reflects on a decade of collaboration with HCPs, recommends Janssen COVID booster

RoundupsRoundups | 16 December 2021 |  By 

The European Medicines Agency (EMA) recently released a report that reflected on a decade of implementing a framework to better work with doctors, pharmacists, and nurses in the EU.
As of December 2021, there are now 38 eligible organizations working with the agency in a variety of practice areas. The framework is designed for EMA to access a network of independent experts in clinical practice who can advise on real-world experience with drug development, benefit-risk evaluation, and monitoring. Another important goal of the framework is understanding ways to better communicate information to healthcare professionals and learn about how they perceive the actions and role of the EU medicines Regulatory Network.
“Healthcare professionals are present in all aspects of medicines regulation as members of committees and expert groups, in addition to the specialists that are invited on specific issues. The perspective of the practicing clinician or community/hospital pharmacist or specialist nurse brings a beneficial viewpoint to the discussions,” the agency wrote.
Future goals of the framework will be aligned with the agency’s regulatory science strategy for 2025, EMA said, with further opportunities to work within the framework to achieve goals of greater use of adaptive design for clinical trials, personalized medicine, real-world evidence, and publicly available clinical data.
EMA framework of interaction with healthcare professionals: 10 years of implementation
ANSM authorizes early access to COVID-19 monoclonal antibody combo Evusheld in France
The Agence nationale de sécurité du médicament et des produits de santé (ANSM) in France has authorized early access to AstraZeneca’s Evusheld as pre-exposure prophylaxis for COVID-19 in adults.
The agency said Evusheld should be used by individuals 18 years and older who are ineligible for COVID-19 vaccination or experienced a poor response to vaccination and are at high risk of severe COVID-19. They recommended against using Evusheld in people with at least two cardiovascular risk factors such as dyslipidemia, diabetes, obesity, hypertension, smoking, or older age.
Evusheld, a combination of monoclonal antibodies tixagevimab (AZD8895) and cilgavimab (AZD1061), was authorized for use by the US Food and Drug Administration (FDA) in December as pre-exposure prophylaxis for adolescents and adults 12 years and older who are severely immunocompromised or ineligible to receive a COVID-19 vaccine due to a history of adverse vaccine reactions.
It has also been authorized as a COVID-19 treatment in Bahrain. EMA’s human medicines committee (CHMP) has been conducting a rolling review of Evusheld as a COVID-19 preventative since October.
EFPIA comments on European Parliament adoption of Health Technology Assessment Regulation
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has put out a statement noting the Health Technology Assessment (HTA) Regulation has been adopted by the European Parliament and will be published in the Official Journal of the European Union.
The new regulation would allow joint health technology assessments and scientific consultations between EU Member States.
“EFPIA strongly supports a system to pool resources and high level expertise so that medicines can be assessed jointly for their relative effectiveness on the basis of clinical evidence and that joint early scientific dialogue can take place with HTA agencies. In order to preserve the spirit of such a system it is of utmost importance that the process leads to high-quality joint clinical assessment reports and their de-facto use by decision-makers at national level,” they wrote.
In its current form, the HTA Regulation gives Member States the option to opt in to whether to conduct joint clinical assessments, EFPIA said, and future efforts should focus on national adaptation, inclusion of manufacturers in assessments, development of methodological guidelines, and allocation of capacity and resources for joint scientific consultations.
“EFPIA stands ready to meaningfully contribute through the work of EUnetHTA-21, the work of the Coordination Group, the development of implementing acts and at national level towards ensuring that the future system for joint clinical assessments delivers for patients and that the objective of timely access to innovative medicines is secured,” they said.
EFPIA statement on adoption of Health Technology Assessment Regulation
New from EMA: a report on regulatory science research needs
In an agency first, the EMA has created a list of areas in regulatory science that need further research. The 38-page document details approximately one hundred different topic areas in categories of integration of science and technology in medicines development, collaborative evidence generation, patient access to medicines, and emerging health threats.
While developing Regulatory Science Strategy to 2025, EMA engaged in consultations with stakeholders, which led to the development of this initiative. The report’s goal is to encourage funding from organizations and spur interest from researchers to address these unmet regulatory research needs.
“The acceleration of innovation in medicines development requires a parallel advancement in regulatory science. New technologies and evolving science throw up new regulatory questions and it is important that these questions are answered so that innovation is translated safely and swiftly into effective, high-quality therapies,” EMA wrote in its executive summary.
EMA encouraged interested parties to contact the agency, and said it is planning a launch event webinar in January 2022 to provide information on the regulatory science research needs initiative.
Regulatory Science Research Needs (version 1.0)
EMA endorses statement from ICMRA on need for new COVID-19 therapeutics
Both the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) agree that vaccines aren’t enough to combat the COVID-19 pandemic. There should also be a continued focus on the development of new COVID-19 therapeutics, according to a recent statement from ICMRA.
“While vaccines remain the main weapon in our fight against the pandemic, we also need safe, effective and high-quality medicines to treat and prevent COVID-19, in all its manifestations and in all populations, including children and pregnant women,” Emer Cooke, Chair of ICMRA and EMA’s Executive Director, said in the statement. “ICMRA members are committed to continue efforts to streamline regulatory requirements for COVID-19 medicines to improve the accessibility and availability of COVID-19 therapeutics that complement vaccination, in particular in low- and middle-income countries.”
Endorsing the statement, EMA said stakeholders should focus on treatments and preventative therapeutics for COVID-19, while regulatory agencies review requirements “to enable rapid development, approval and global roll-out of safe and efficacious medicines against COVID-19.”
International regulators stress continued need for COVID-19 therapeutics
EMA recommends booster dose of Janssen’s COVID-19 vaccine
Individuals 18 years or older who received COVID-19 Vaccine Janssen may get a booster dose 2 months after their initial dose, according to a recent recommendation from EMA’s human medicines committee (CHMP).
A “booster dose” of COVID-19 Vaccine Janssen is considered by CHMP to be a second dose of Janssen’s vaccine, or a dose of COVID-19 Vaccine Janssen following a Comirnaty or Spikevax two-dose primary series.
The recommendation stems from data in the Phase 3 ENSEMBLE 2 trial announced by Johnson & Johnson in a September press release. ENSEMBLE 2 evaluated a COVID-19 Vaccine Janssen booster dose in 14 participants compared with 52 patients who received a placebo. The results showed a second dose given 56 days after the first raised protection against severe disease to 100% in a small group of patients. The same trial showed a booster dose of COVID-19 Vaccine Janssen resulted in 75% protection against symptomatic disease globally and 94% protection against symptomatic disease in the US.
Many countries have authorized or approved Janssen’s COVID-19 vaccine for emergency use, but few have allowed the use of booster doses. Notably, FDA authorized the use of so-called mix-and-match booster doses in October for certain individuals 18 years and older.
COVID-19 Vaccine Janssen: EMA recommendation on booster dose
EMA reviewing more data from COVID-19 therapeutic Lagevrio
After EMA said it would allow national authorities to use Merck Sharp & Dohme’s COVID-19 therapeutic Lagevrio (molnupiravir) prior to making a decision on its marketing authorization, the agency said it is not changing that recommendation, but is reviewing new data.
In October, Merck and Ridgeback Bio announced results from their Phase 3 MOVe-OUT trial, which showed non-hospitalized patients with COVID-19 who received Lagevrio had a 50% reduced risk of hospitalization or mortality. However, the companies provided an updated analysis in November that lowered that reduced risk of hospitalization and mortality to 30%.
Following EMA’s recommendation, Denmark became the first EU country to allow use of Lagevrio as a COVID-19 treatment on 16 December.
EMA noted that it is reviewing this updated data and is still evaluating Lagevrio’s marketing authorization application, which it received 23 November. Lagevrio has been approved for emergency use in the United Kingdom and in Bangladesh. In the US, an FDA advisory committee narrowly voted to recommend Lagevrio for emergency use authorization (EUA), but the agency has yet to make a decision on whether to issue an EUA for the therapeutic.
EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you