Euro Roundup: EMA drug shortage group backs continued COVID exceptions

| 14 July 2022 | By Nick Paul Taylor 

The regulatory flexibilities offered to ease the impact of COVID-19 should be continued for now, according to the members of the European Medicines Agency’s (EMA) Medicines Shortages Steering Group (MSSG). The group, formed earlier this year to plan for future crisis preparedness, met for the fourth time on 7 July.
EMA, the Heads of Medicines Agency, and the European Commission adopted the measures in 2020 to accelerate the authorization of COVID-19 interventions, support the continued supply of medicines, and mitigate the impact of travel disruptions on certain regulatory activities. MSSG said the measures have been “adequate and effective.”
EMA has reviewed whether the measures are still needed as the pandemic has evolved. The latest assessment concluded that, while the flexibilities are being used less and less, “they remain crucial to enable timely availability of medicines in certain cases and their use may have to be expanded again should the situation deteriorate.”
European regulators will assess the need to offer the flexibilities to individual applications on a case-by-case basis.
MSSG also adopted the list of the main therapeutic groups (MTGs) for emergency care, surgery and intensive care medicines. The list of medicinal products that are necessary in each MTG will inform the creation of future lists of critical medicines during public health emergencies.
In times of crisis, products added to lists of critical medicines will be subject to reporting requirements and monitoring of supply and demand to identify and manage actual and potential shortages.
MSSG created its MTG list after consulting with working parties and industry associations. The group will review the list annually, reassessing its choices considering developments such as changes in clinical practice.
EMA Notice, More
EMA adopts reflection paper on using MRD to assess clinical efficacy
EMA has adopted a reflection paper on the use of minimal residual disease (MRD) as a clinical endpoint in multiple myeloma clinical trials. The paper identifies a need to confirm the quantitative relationships between MRD negativity and clinical outcomes, leading EMA to advise sponsors to seek advice before using it as the primary endpoint.
MRD has emerged as a potential way to predict the durability of responses to cancer therapies. Among patients who have complete responses, individuals with detectable MRD seem to have shorter overall and progression-free survival than their peers with undetectable MRD. If MRD negativity predicts clinical outcomes, it could allow sponsors to seek approval without waiting years for survival data.
While EMA acknowledges the correlation “at the patient level,” it sees “uncertainties about the quantitative aspects on the predictive association” between MRD negativity and clinical outcomes. As such, the reflection paper concludes that the use of MRD outcomes as the primary endpoint in clinical trials “is currently unclear.”
EMA plans to update the reflection paper as “significant” new evidence of the association emerges. For now, the agency is advising sponsors that want to use MRD negativity as the primary endpoint in trials intended to inform regulatory decisions to get scientific advice. When reviewing marketing authorization applications, EMA will carry out case-by-case assessments that consider the current evidence limitations.
The reflection paper supersedes a draft guideline that EMA released for consultation in 2018. In the draft, EMA proposed allowing the use of MRD negativity as the primary evidence of clinical benefit in filings for early licensure. The approach would have allowed sponsors to seek approval while waiting for the survival data to mature.
EMA Update, Reflection Paper
ECDC, EMA support expansion of second COVID booster programs to the over 60s
EMA and the European Center for Disease Prevention and Control (ECDC) have a second booster shot of mRNA vaccines for people aged 60 years and up.
In April, EMA and ECDC advised member states to offer a second booster to people aged over 80 years, while acknowledging that it may be necessary to lower the threshold if there is a resurgence in COVID-19 cases. The European Union averaged more than 900 daily COVID-19 cases per million people over the past seven days, compared to around 250 in the first week of June.
“This signals the start of a new, widespread COVID-19 wave across the European Union. There are still too many individuals at risk of severe COVID-19 infection whom we need to protect as soon as possible,” said ECDC Director Andrea Ammon.
The current wave is causing rates of hospital and intensive care admissions to rise, leading the agencies to reconsider their advice. EMA and ECDC are advising public health authorities to offer second boosters to the over 60s and vulnerable people of any age. Authorities should leave a gap of four months between boosters and focus on people who received their previous shot more than six months ago, the agencies said.
EMA and ECDC continue to advise that there is no clear evidence to support offering second boosters to younger people who are not at higher risk of severe disease, including those who work in healthcare settings and long-term care homes.
EMA Notice
PRAC calls for restrictions on use of women’s health medicines over tumor risk
The EMA Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of medicines containing nomegestrol or chlormadinone to minimize the risk of tumor development.
The committee identified meningioma, a usually benign tumor of the membranes covering the brain and spinal cord, as a rare side effect of the active ingredients, mainly when they are used at high doses. The ingredients are used for gynecological and menstrual disorders, hormone replacement therapy and, at lower doses, as birth control.
PRAC has recommended using high-dose formulations of the ingredients at the lowest effective dose and for the shortest possible duration. Even then, the committee wants to limit use to situations in which no other interventions are appropriate. PRAC is also advising against the use of any nomegestrol or chlormadinone products in patients who have a history of meningioma.
The committee also initiated a review of the risk of neurodevelopmental disorders with topiramate. Johnson & Johnson brought the ingredient to market, branded as Topamax, in 2009 on the strength of efficacy against seizures and migraine headaches.
Women taking the drug are already advised not to become pregnant because of the risk of birth defects. A study linking topiramate use in pregnancy to a possible increase in autism spectrum disorders, intellectual disability and child neurodevelopmental disorders has persuaded PRAC to review the data.
EMA Notice, More


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