Euro Roundup: EMA seeks feedback on planned COVID antiviral, antibody guidance

The European Medicines Agency (EMA) has released a draft concept paper outlining its plans to create guidance on developing antivirals and monoclonal antibodies to treat and prevent COVID-19.

During the pandemic, EMA authorized antivirals including Gilead Sciences’ Veklury (remdesivir) and Pfizer’s Paxlovid (nirmatrelvir/ritonavir) and anti-SARS-CoV-2 antibodies including Celltrion’s Regkirona (regdanvimab) and Roche’s Ronapreve (casirivimab/imdevimab). Those companies developed the drugs without EMA guidance, specifically about molecules that prevent or treat COVID-19 by targeting SARS-CoV-2. However, EMA now sees value in providing such guidance.

“While the public health emergency has passed, the virus continues to evolve and to cause significant morbidity and variable mortality,” EMA wrote in a draft concept paper. “There is a need for guidance built on experience so far that addresses appropriate and feasible clinical study designs, including study populations, endpoints and, where appropriate, choice of active comparators.”

EMA’s desire to create guidance is also informed by a joint workshop held with the US Food and Drug Administration (FDA) in December 2022. At the event, immunobridging approaches were agreed upon for antibodies manufactured on the same platform technology as approved monoclonal antibodies. The agreement led EMA to identify a need for guidance on immunobridging strategies to accelerate drug development.

Immunobridging is one of six topics EMA plans to discuss in the guidance. The agency also wants to cover non-clinical assessments of antiviral activity, clinical trial designs, primary endpoints, specific safety considerations and pediatric requirements.

EMA has published the draft concept paper to gather feedback on its plans. The consultation, which will close 30 April, will inform the development of a draft guideline by the Emergency Task Force and the infectious diseases working party. EMA has yet to share a timetable for creating the draft guideline.

Concept Paper

Groups voice ‘deep concerns’ about European Health Data Space draft text

After seeing a draft of the text that is currently being negotiated, healthcare organizations have expressed “deep concerns” about the European Health Data Space (EHDS).

European Union institutions are negotiating to finalize the EHDS proposals that the Commission put forward in 2022. The Council and Parliament agreed on their positions late last year and are now discussing to agree on a text for European politicians to vote on. With the summer recess on the horizon and the Commission’s mandate ending in October, there is a case for finalizing the text quickly.

However, pharma trade group EFPIA, its medical device counterpart MedTech Europe and other groups are concerned that negotiators have so far failed to address their key concerns. Trade groups have raised concerns repeatedly in recent months but say 10 “fundamental issues” are still yet to be addressed.

“The draft text of the EHDS does not provide the necessary degree of legal certainty and consistency with the existing regulatory frameworks,” the groups wrote. “Recently incorporated or amended key provisions should be carefully considered to avoid unintended negative consequences.”

They call for “clearer and more coherent definitions” of terms such as electronic health data, clarification of the interactions between EHDS and other legislation, such as the Medical Device Regulation (MDR), and harmonized rules to ensure consistent implementation across the EU.

The groups also reiterated long-standing concerns about the proposals for opting in and out of EHDS. The Parliament wants to add an opt-out system for the secondary use of most health data and make a patient’s explicit consent mandatory for the secondary use of certain sensitive data. The trade groups want reassurances that an opt-out mechanism will not create inconsistencies and burdens.

Press Release

EMA sides with Spain over Lithuania in a row about authorization of ibuprofen product

EMA has recommended suspending the authorization of an ibuprofen product after reviewing details of a disagreement between regulatory agencies in Lithuania and Spain.

The disputed product, Ibuprofen NVT, contains 400 mg ibuprophen in soft capsules and is authorized in Lithuania. The authorization holder, Laboratorios Liconsa, then used the paperwork from Lithuania to apply to sell the product in Spain. The member states could not agree, leading the Lithuanian agency to refer the matter to EMA.

“The grounds for the referral were concerns raised by the Spanish medicines agency, which considered that Ibuprofen NVT 400 mg was not bioequivalent to the reference medicine,” EMA wrote. “The Spanish agency had concerns about the average time it takes for the active substance to reach its maximum level, as this measure was higher with Ibuprofen NVT 400 mg than with the reference medicine.”

EMA shares the concerns of the Spanish agency. According to EMA, the time for the active substance to reach its maximum level differed for Ibuprofen NVT 400 mg and the reference product. That finding led EMA to conclude the benefits of Ibuprofen NVT 400 mg do not outweigh the risks.

EMA advises against the authorization of the product in Spain and recommends suspending all existing authorizations. Ibuprofen NVT 400 mg is authorized for use in Lithuania, Estonia, France, Latvia, Poland and Romania.

EMA Notice

Off-patent drugmakers praise European Parliament’s IP protection certificate proposals

Medicines for Europe has praised the European Parliament’s “balanced stand” on unitary supplementary protection certificates as “a significant milestone for innovation and access to medicines.”

SPCs extend the patent protection for authorized pharmaceuticals to offset the time it takes to develop medicines. The EU has been working to add “unitary protection” that covers countries where drugs are generally not launched or are only launched after a delay. Adrian van den Hoven, director general of Medicines for Europe, discussed Parliament's position on the topic.

“The position of the Parliament goes in the right direction and rightfully bans patent linkage,” van den Hoven said. “The pre-grant opposition will ensure a timely grant of SPCs for innovative drugs (a maximum 14 months or 12 with an expedited procedure) and prevent monopoly extensions for those drugs that do not have a legal right to an SPC because they are not innovative.”

Medicines for Europe states patent linkage causes “undue delays” to generic medicines. The trade group cited seven products that were collectively delayed by more than 2,500 days, causing more than €300 million ($325 million) in lost savings.

Press Release

Euro Roundup: EMA seeks feedback on planned COVID antiviral, antibody guidance

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