Euro Roundup: CHMP recommends drugs from Biogen and Roche, knocks back Pfizer filing

RoundupsRoundups | 23 September 2021 |  By 

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended nine medicines including Biogen’s Vumerity (diroximel fumarate) and Roche’s Gavreto (pralsetinib) for approval.
CHMP voiced support for the approval of RET receptor tyrosine kinase inhibitor Gavreto in non-small cell lung cancer on the strength of data from a Phase I/II clinical trial. Biogen received the backing of the committee for its multiple sclerosis drug Vumerity after showing bioequivalence to Tecfidera. Vumerity is an oral delayed-release product that may have quality of life benefits over Tecfidera.
The recommendations for Gavreto and Vumerity were two of nine positive decisions by CHMP, which also gave its blessing to treatments of severe malaria and a rare type of non-Hodgkin lymphoma from Amivas and BeiGene, respectively.
CHMP also recommended extensions to the approved indications of nine medicines. The set of label extension recommendations included support for the use of GlaxoSmithKline’s Nucala (mepolizumab) in three new diseases including eosinophilic granulomatosis with polyangiitis.
Finally, CHMP issued a negative opinion on Pfizer’s proposed treatment of pain associated with osteoarthritis, Raylumis (tanezumab). CHMP ruled the benefits do not outweigh the risks after assessing the lack of improvement in pain relief compared with non-steroidal anti-inflammatory drugs and the risk of side effects such as joint replacement.
CHMP Statement
European politicians demand an EU action plan for ending animal testing
Politicians have called for the European Commission to create an action plan for phasing out the use of animals in research. The text adopted by the European Parliament states the Commission needs to  set “a clear and ambitious timeline” to ensure change happens “as soon as scientifically possible.”
The European Union banned animal testing for cosmetic products in 2009. However, animals remain critical to the early stages of the drug development process. In 2017, the use of animals for scientific purposes was reported 10 million times. Most of the animals were used for research into human medicines. Almost one-quarter were involved in regulatory work to satisfy legislative requirements. A further 12 million animals were bred and killed without being used in actual experiments.
Strategies to reduce and replace animal testing are already in place at bodies including EMA. The politicians see scope to accelerate the process and have called for the creation of an action plan to drive “active phase-out by reducing, refining and replacing procedures on live animals for scientific and regulatory purposes.”
The request notes that “non-animal methods are not yet available across all scientific research areas” and states the move to new approaches must not lower “the level of protection for human health and the environment.” The politicians want the Commission to accelerate work on alternative tests, including by making “sufficient medium- to long-term funding available.” Alternatives to animals for “key toxicological endpoints” are particularly sought after by the politicians.
What happens next depends on the response of the Council and the Commission. In Europe, it is the Commission that proposes legislation for consideration by the Council and the Parliament. The text adopted by Parliament and sent to the two other legislative branches of the EU states broad goals, such as the need to set “ambitious and achievable objectives, reduction targets and timelines,” but lacks the specific details that will dictate what the policy means for companies that test on animals.
Press Release, Adopted Resolution
UK implements new reporting standards for clinical trials to drive transparency
The UK Health Research Authority (HRA) has implemented new reporting standards. Under the new system, health and social care researchers must send HRA information about the fulfillment of their transparency responsibilities upon the completion of their studies.
In 2018, a political committee found, “HRA appears to be reluctant to enforce its transparency rules” in a report that found half of studies lack published results. HRA has since embarked on a campaign to improve transparency, including by creating a new reporting requirement intended to help it check that researchers communicate the results to participants at the end of the study.
The requirement for researchers to submit information to HRA online about how they met their transparency responsibilities took effect last week. HRA is now working on a raft of other measures to address different aspects of research transparency.
By January, HRA is aiming to “deliver and manage UK based, automatic registration of UK clinical trials.” Other goals for next year include the creation of a research summaries webpage and a policy for factoring performance against transparency requirements into the research approval process. The factoring of prior performance into the review of new studies is central to HRA’s sanctions agenda. 
HRA Notice
Spain extends deadline for updating labels in light of new EU-Swiss relationship
The Spanish Agency of Medicines and Medical Products (AEMPS) has given medical device companies another year to make labeling changes necessitated by the change in the relationship between the EU and Switzerland.
In May, the failure of EU and Swiss negotiators to update a mutual recognition agreement to cover the Medical Devices Regulation ended a period of barrier-free trade between the two sides. AEMPS set out the implications of the split between the EU and Switzerland for the medical device industry in a notice published in June.
The Spanish regulator gave medical device companies until the end of September to update their labels and instructions for use in light of changes to the notified bodies and the appointment of new authorized representatives. AEMPS said the timeline reflected the difficulty the changes entail.
However, AEMPS has now accepted the industry will need more time, prompting it to extend the deadline until the end of September 2022. AEMPS said the delay is needed because of the difficulty the revisions are posing to medical device companies and the limited warning they had about changes to the EU-Swiss relationship.
AEMPS Notice (Spanish)
Commission opens new front in fight against closing of $8B Illumina-Grail merger
The European Commission has proposed interim measures in response to Illumina’s decision to close its $8 billion takeover of liquid biopsy developer Grail without waiting for regulatory approval.
Illumina closed the takeover because it was set to expire before the Commission’s ruling and is now facing the consequences of its action. Foreseeing the Commission’s response, Illumina agreed to hold Grail separate when it closed the deal, but the interim measures go further to address “a number of serious shortcomings” the EU body has identified in the voluntary actions.
The Commission is set to impose the measures, full details of which are yet to emerge, after giving Illumina and Grail a chance to comment. Once the legally binding interim measures are in place, the Commission could fine Illumina and Grail up to 10% of their annual worldwide turnover for failing to comply with the requirements.
The interim measures are part of a broader tussle between the Commission and the companies. The Commission is investigating whether the merger infringed its rules in a probe that could see it fine the companies 10% of their annual worldwide turnover. Meanwhile, Illumina is awaiting rulings from the Commission on the merger and a court on the right of the EU to intervene in the deal.
Press Release
Other News:
The Swiss Agency for Therapeutic Products (Swissmedic) has shared guidance on combination products. Swissmedic Notice


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