EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to examine safety data that have recently become available.
Continuing a cascade of positive news for Stereotaxis Inc., the company reported the first order for its petite Genesisx robot in Europe. The system received CE mark in August, but management held off its launch until its Magic radiofrequency ablation catheter also received CE mark, which happened on Jan. 27. The two devices are used together to treat cardiac arrhythmias.
The EMA has started a review of Novo Nordisk A/S’ GLP-1 receptor agonist, semaglutide, after the Danish regulatory agency raised the possibility it causes an increased risk of suffering from an acute eye condition. After the first report in July 2024, the Danish regulator had received, by Dec. 10, 2024, a total of 19 reports of non-arteric anterior ischemic neuropathy, a rare condition that affects the small blood vessels at the front of the optic nerve. This can lead on to sudden vision loss and visual field defects.
The EMA recommended the highest number of approvals in the last 15 years in 2024, giving the nod to 114 drugs. That is amongst the highest number in the 30 years of the agency’s existence, said Steffen Thirstrup, the EMA’s chief medical officer.
Timing is everything. Just days after confirming a pause in the U.S. rollout of its Varipulse pulsed field ablation (PFA) catheter, Johnson & Johnson’s electrophysiology program received an epic reprieve from European regulators who granted the company’s dual-energy Thermacool Smarttouch SF catheter CE mark.
The U.K. is embarking on the biggest overhaul of clinical trials regulations in 20 years in a bid to retake ground that was lost following Brexit, when the Medicines and Healthcare products Agency was excised from the EMA’s regulatory system.
As 2025 gets underway, a new European Commission will start work on its new five-year mandate, with plans for multiple pieces of legislation that have implications for biotech and pharma – and the life sciences industry more broadly – due to be put forward.
The EMA’s Committee for Medicinal Products for Human Use recommended 17 drugs for approval at its December meeting, bringing the total for 2024 to 114. That is up from the 77 drugs recommended for approval in 2023, of which 39 were novel.
The conditional marketing approval for Ocaliva (obeticholic acid) has been revoked with immediate effect, following a standoff between the EMA and Advanz Pharma Ltd., the company that markets the primary biliary cholangitis (PBC) therapy in Europe. On Sept. 5, London-based Advanz won a short reprieve after challenging the EMA’s June 28 ruling that the marketing authorization for Ocaliva should be revoked, when the General Court of the EU granted a temporary suspension of EMA’s decision. However, on Nov. 27, Advanz announced the court had said it would not be extending the suspension.
The EMA has changed its mind about an earlier decision that the risks of Leqembi (lecanemab) outweigh the benefits and is now recommending the Alzheimer’s disease drug is approved for a subgroup of patients. That follows an appeal by Eisai Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file.
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