Euro Roundup: EFPIA pushes for shorter trial approval times in EU Biotech Act
EFPIA has called for lawmakers to go beyond the reductions in clinical trial approval times proposed in the Biotech Act.
Through the Biotech Act, the European Commission has proposed shortening clinical trial authorization timelines across the European Union. The legislation would cut the timeline for approving multinational trials from 106 days to 75 days. Reviews could take as little as 47 days when no additional questions are raised. Other changes could remove delays for cell and gene therapies.
Responding to the proposals, EFPIA, a trade group representing large pharma companies, called the new timelines “one of the most important improvements proposed in the Biotech Act.” Shorter reviews will allow medicines to enter the clinic sooner, give patients earlier access to treatments, and improve the predictability of the process for sponsors, EFPIA said.
Yet EFPIA wants the EU to further accelerate reviews of applications to run clinical trials in the EU. Calling the current proposals a “welcome step,” the trade group argued that the planned timelines fall short of the emerging global benchmark.
“The EU should pursue further reductions in approval timelines while maintaining high standards of patient safety, ethics, and scientific quality, supported by adequate resources,” EFPIA said. “Globally, clinical trial authorization timelines continue to accelerate, with 30-day competent authority reviews followed by ethics review increasingly becoming the benchmark.”
Last year, MHRA and China’s National Medical Products Administration (NMPA) proposed 30-day reviews of some trial filings. MHRA’s 30-day timeline applies when it can reach a decision without consulting a committee or specialist group. NMPA established a 30-day review for certain innovative drugs.
EFPIA’s feedback to the Commission also addressed the proposed 12-month Supplementary Protection Certificate (SPC) extension for biotechnology products and advanced therapies. Again, the trade group welcomed the proposal while pushing for enhancements. The extension should be broadened to cover all innovative medicines and be supported by clear, predictable, and attainable award criteria, EFPIA said.
MHRA clarifies regulatory status of AI scribes used in UK healthcare service
The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance clarifying how UK medical device law applies to AI scribes.
AI scribes, which MHRA calls ambient voice technology products, record and summarize conversations between clinicians and patients. Increasingly used across the UK healthcare service, the technology can cut time spent on administrative tasks and summarize clinicians’ conversations with patients. Agencies including Australia’s Therapeutic Goods Administration have grappled with how to regulate the tools.
Working with the English healthcare service, MHRA has created guidance confirming that many products are not regulated as medical devices under the current framework. Products outside of the scope of the UK medical device regulation include tools that are intended solely for transcribing, summarizing clinical conversations, drafting letters, or suggesting clinical codes for a clinician to review.
AI scribes with capabilities beyond those core features may be classed as medical devices. The medtech regulations apply to products that support diagnosis, treatment, or prevention of disease or that act autonomously, for example by placing orders without clinician review. AI scribes regulated as medical devices must meet the relevant safety and performance requirements.
The guidance includes examples of products that are regulated as medical devices, as well as examples of tools that are outside of the scope of the regulations. A product that includes an option for “generated insights” based on a conversation between a clinician and a patient would meet the definition of a medical device. The tool’s ability to generate insights for diagnosing people makes it a medical device.
MHRA’s guidance explains how UK rules on classifying medical devices apply to AI scribes. Products that are intended to allow direct diagnosis or monitoring of vital physiological processes fall into Class IIa and require certification by an approved or notified body. Class IIa may apply to AI scribes that determine the probability of a patient having a disease or condition. Other products will fall into the lower-risk Class I.
Products may come under the scope of the medical device regulation as developers add new features. Software companies are increasingly designing AI scribes with flexible underlying technology, enabling them to rapidly deploy more complex uses beyond the scope of the initial intended purpose, MHRA said.
“As these products begin to offer additional features and means of integration into the increasingly digital healthcare ecosystem, it is important that each of a product’s functionalities is considered in context of its specific intended purpose, risks, and benefits,” MHRA said. “Manufacturers should assess the application of the device regulations with every change of their product.”
MHRA finds insufficient evidence to confirm bladder drugs pose dementia risk
MHRA’s review of a potential link between bladder anticholinergics and dementia has found insufficient evidence to confirm the risk.
Anticholinergic drugs block the action of acetylcholine, a chemical found in the brain and other parts of the body. The mechanism of action can help control bladder function. In recent years, researchers have studied whether people who take anticholinergic medicines have a higher risk of dementia, leading the UK Commission on Human Medicines to recommend that MHRA review the data.
“The overall findings of the review are that the available evidence is not sufficient to confirm that use of bladder anticholinergic medicines directly increases the risk of developing dementia; however, the limitations of these studies mean that a small increased risk cannot be ruled out completely,” MHRA said.
MHRA reviewed data showing that the anticholinergic oxybutynin can cause short-term memory loss and negatively affect attention and thinking. The data does not suggest that other bladder anticholinergic medicines have similar adverse effects, MHRA said.
While the evidence is inconclusive, MHRA advised older adults to limit the number of anticholinergic drugs they take and use the lowest dose to control their condition for the shortest length of time. The advice reflects evidence that taking multiple anticholinergic medicines increases the risk of side effects, as well as data showing the body’s ability to process medicines deteriorates as people age.
EMA recommends approval of first oral IL-23 treatment for plaque psoriasis
The European Medicines Agency (EMA) has recommended Icotyde for approval, positioning Johnson & Johnson to be the first drugmaker to launch an oral IL-23 treatment for plaque psoriasis in the EU.
Icotyde, which won FDA approval in March, blocks the action of IL-23 to reduce inflammation and plaque psoriasis symptoms. Injectable anti-IL-23 drugs are available in the EU, but Icotyde would be the first oral treatment targeting the receptor. EMA recommended the molecule for approval based on data from four clinical trials that linked the treatment to improvements in the area and severity of psoriasis.
EMA made the recommendation, which has passed to the Commission to inform an approval decision, at a recent meeting of its human medicines committee. Icotyde was one of 12 new drugs recommended for approval at the meeting. GSK’s Lynavoy and Roche’s Susvimo were among the other products to receive EMA recommendations. The agency also issued negative opinions for three medicines.
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