October 2025 • PharmaTimes Magazine • 9
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Lundbeck unveils migraine data for eptinezumab at international congress
Lundbeck has presented new clinical data on eptinezumab at the 2025 International Headache Congress in São Paulo, highlighting its long-term preventive effectiveness in patients severely affected by chronic migraine.
The company shared six presentations, including three oral sessions on eptinezumab and Lu AG09222. Key findings came from the open-label extensions of the RESOLUTION and SUNSET trials.
In the phase 4 RESOLUTION trial, patients with chronic migraine and medication overuse headache showed sustained reductions in monthly migraine days (MMDs). Around 50% achieved a ≥50% reduction from baseline, with an average decrease of nine MMDs over 12 weeks.
The SUNSET trial, a 60-week extension of the SUNRISE study in Japanese patients, confirmed long-term efficacy. By weeks 49–60, 35.7% of participants achieved a 50% reduction in MMDs, with a rising trend in ≥75% response rates.
Eptinezumab was well tolerated across both trials, with safety profiles consistent with previous studies and existing prescribing information in the US and EU. No new safety signals were reported.
Dr Johan Luthman, EVP and Head of Research & Development at Lundbeck, said: “Patients deserve preventive treatments that not only deliver early relief but sustain their impact over time. The RESOLUTION and SUNSET trials show that patients who experience an early, clinically significant response with eptinezumab continue to maintain this response long-term.”
Lilly receives UK approval for pirtobrutinib in relapsed blood cancers
Eli Lilly and Company has received conditional marketing authorisation from the MHRA for pirtobrutinib (Jaypirca) as monotherapy for adults with relapsed or refractory mantle cell lymphoma (MCL) or chronic lymphocytic leukaemia (CLL) previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor.
The decision is based on data from two clinical trials: BRUIN CLL-321, the first randomised phase 3 trial in CLL exclusively involving patients previously treated with a BTK inhibitor, and BRUIN, a phase 1/2 study in B-cell malignancies including MCL.
Pirtobrutinib is a reversible BTK inhibitor designed to address treatment resistance in patients who have progressed on covalent BTK therapies. The approval provides a new option for patients with limited alternatives.
Toby Eyre, Consultant Haematologist at Oxford University Hospital NHS Foundation Trust, said: “As a newly licensed treatment option, pirtobrutinib provides an additional treatment option for eligible patients in the UK with relapsed or refractory MCL and CLL, particularly in the post-covalent BTK inhibitor setting.”
Hilary Lindsay, Chair of Trustees at CLL Support Association, said: “For people living with chronic lymphocytic leukaemia (CLL), the availability of additional treatment options can make a difference. Every new option means greater choice for patients and their healthcare teams. We know how important it is for treatments like this to reach eligible patients.”
HOT & NOT
Novartis has reported that its experimental drug ianalumab met the primary goal in a phase 3 trial for primary immune thrombocytopenia (ITP), a rare autoimmune condition where the immune system destroys platelets, increasing the risk of bleeding and fatigue.
The study, VAYHIT2, investigated ianalumab alongside eltrombopag in patients whose disease had not responded to corticosteroids – a conventional means of treatment. Results showed that patients receiving ianalumab maintained safe platelet levels for longer than those given a placebo.
Encare’s ERAS Interactive Audit System (EIAS) has earned qualification on the Mayo Clinic Platform_Solutions Studio – a distinction rarely awarded to European solutions. The recognition positions EIAS for faster adoption across Mayo Clinic medical centres and partner health systems worldwide.
Developed in collaboration with the Enhanced Recovery After Surgery (ERAS) Society, EIAS enables hospitals to monitor and improve adherence to ERAS protocols across multiple surgical specialties.
lzeCure Pharma has presented new clinical data on its lead pain candidate ACD440 at the NeuPSIG 2025 international pain conference. The presentation included results from the phase 2 study in chronic peripheral neuropathic pain.
ACD440 is a first-in-class TRPV1 antagonist developed as a topical gel for localised treatment. It is designed to minimise systemic exposure while maintaining high local concentrations for sustained analgesic effect.
Resolution Therapeutics has dosed the first patient in its phase 1/2 EMERALD study of RTX001, a first-in-class engineered regenerative macrophage therapy (RMT) for end-stage liver disease. The study is now open for enrolment in the UK and Spain.
RTX001 is the first engineered RMT to be evaluated in humans with advanced liver fibrosis. The EMERALD study is a multi centre trial assessing safety and efficacy in patients who have recovered from hepatic decompensation.
Health Secretary Wes Streeting has warned NHS leaders there is “nowhere to hide” as new league tables reveal 99 of 134 major NHS trusts in England are overspending.
Nearly three-quarters are in debt, with 38 Trusts falling to the lowest tiers due to financial mismanagement, despite good medical care. Streeting pledged a crackdown on wasteful spending and rejected increasing the £200 billion health budget without significant reforms.
The NHS faces possible strikes this autumn unless plans to transfer thousands of workers out are stopped, warns Unison.
The union told ministers there will be “no place to hide” if Trusts continue outsourcing support services to subsidiaries. Unison has submitted a motion on the issue for debate at the TUC Congress in Brighton. It called the proposals a “direct contradiction” of Labour’s pledge to reverse privatisation.
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