Eisai focuses on oncology as a major area and strives to contribute to cancer cures by delving deeply into human biology. The development of FZEC for treatment-resistant cancers demonstrates our commitment to meeting the unmet needs of cancer patients. Eisai will persist in its efforts to enhance the benefits for patients with cancer and their families.
Nipocalimab Phase III Trial Shows Unprecedented Long-Term Disease Control in FcRn Class
Johnson & Johnson reported favorable outcomes from the nipocalimab Phase III Vivacity-MG3 study for patients with generalized myasthenia gravis (gMG). Those receiving nipocalimab combined with standard care (SOC) outperformed the placebo group, as indicated by the primary endpoint of improvement in the MG-ADL score over 24 weeks. These findings are part of a presentation and are among eight abstracts that Johnson & Johnson will present at the 2024 European Academy of Neurology (EAN) Congress. They will also be included in submissions to regulatory authorities later this year.
“The prolonged effectiveness of nipocalimab over six months in a diverse myasthenia gravis population is a significant discovery, considering the chronic and unpredictable flare-ups common with this condition,” stated Carlo Antozzi, M.D., from the Neuroimmunology and Muscle Pathology Unit at the Neurological Institute Foundation C. Besta in Milan, Italy. “We are optimistic about nipocalimab’s potential to uniquely address the needs of individuals with myasthenia gravis.”
The study, conducted under double-blind placebo-controlled conditions, included a diverse group of patients who tested positive for anti-AChR, anti-MuSK, and/or anti-LRP4 antibodies, encompassing around 95 percent of the gMG patient population.2 Participants treated with nipocalimab in addition to standard of care (SOC) showed a significant improvement of 4.70 points on the MG-ADL scale, compared to a 3.25 point improvement observed in those receiving placebo alongside SOC over Weeks 22, 23, and 24 (P=0.002)c. For individuals living with gMG, a change of 1 to 2 points on the MG-ADL scale could mean the difference between normal eating and experiencing frequent choking, or between experiencing shortness of breath at rest and requiring a ventilator.
Safety and tolerability were in line with findings from previous nipocalimab investigations. The overall occurrence of adverse events, serious adverse events, and events causing discontinuation was comparable to those observed in the placebo plus standard-of-care group.
Merck Gains Favorable EU CHMP Recommendation for WINREVAIR in Treating Pulmonary Arterial Hypertension
Merck has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of WINREVAIR™ (sotatercept), alongside other therapies for pulmonary arterial hypertension, for treating PAH in adults with World Health Organization (WHO) Functional Class (FC) II to III to enhance exercise capacity. WINREVAIR previously received Priority Medicines (PRIME) and orphan designation from the EMA for PAH treatment. The European Commission (EC) will now evaluate the CHMP’s recommendation, with a decision on WINREVAIR’s marketing authorization application in the EU, Iceland, Liechtenstein, and Norway expected in the third quarter of 2024.
WINREVAIR is given once every three weeks as a single injection under the skin and can be administered by patients or caregivers under the guidance, training, and follow-up of a healthcare provider.
The CHMP’s recommendation stems from data from the Phase III STELLAR trial of WINREVAIR in addition to background PAH therapy, compared to therapy alone. WINREVAIR showed a statistically significant and clinically meaningful enhancement in the 6-minute walk distance, which was the primary endpoint of the study. It also demonstrated improvements in several important secondary outcomes, including a decrease in the risk of death from any cause or PAH clinical worsening events. These findings were published in The New England Journal of Medicine.
The EMA’s CHMP recommendation marks the second regulatory endorsement of WINREVAIR for treating PAH, following a thorough assessment of crucial efficacy and safety data. WINREVAIR (sotatercept-csrk) received FDA approval in March 2024.
Verona Pharma Gains FDA Approval for Ohtuvayre
Verona Pharma plc has reported that the FDA has approved Ohtuvayre (ensifentrine) for the ongoing treatment of chronic obstructive pulmonary disease (COPD) in adults. Ohtuvayre represents the first inhaled product with a new mechanism of action to be offered for the maintenance treatment of COPD in over two decades.
Ohtuvayre represents a novel selective dual inhibitor targeting both phosphodiesterase 3 and phosphodiesterase 4 enzymes (“PDE3 and PDE4”). This compound combines bronchodilator and non-steroidal anti-inflammatory properties within a single molecule. It is administered directly to the lungs using a standard jet nebulizer, eliminating the requirement for high inspiratory flow rates or complicated hand-breath coordination.
David Zaccardelli, Pharm. D., President and CEO of Verona Pharma, described the approval of Ohtuvayre as a major step forward in COPD treatment, suggesting that its unique characteristics could revolutionize how COPD is managed. He indicated plans to introduce Ohtuvayre to the market in the third quarter of 2024, aiming to provide relief for the millions of COPD patients who continue to suffer from daily symptoms.
The US approval of Ohtuvayre relied on comprehensive data from the Phase III ENHANCE trials, whose outcomes were detailed in the American Journal of Respiratory and Critical Care Medicine. These trials showed that Ohtuvayre provided clinical advantages when used alone or in combination with other maintenance treatments for moderate to severe COPD patients. The medication demonstrated good tolerability across a diverse range of subjects.
The Company is fully prepared for the launch and anticipates Ohtuvayre to be accessible starting in the third quarter of 2024 through a dedicated network of accredited specialty pharmacies.
CHMP Recommends EU Approval for Combination of Lynparza and Imfinzi in Treating Mismatch Repair Proficient Advanced or Recurrent Endometrial Cancer
AstraZeneca’s drugs Imfinzi (durvalumab) and Lynparza (olaparib) have received approval recommendations in the European Union for treating specific groups of patients with primary advanced or recurrent endometrial cancer. For patients with mismatch repair proficient (pMMR) disease, the recommendation includes using Imfinzi alongside chemotherapy as first-line treatment, followed by a combination of Lynparza and Imfinzi. For those with mismatch repair deficient (dMMR) disease, the recommendation involves Imfinzi plus chemotherapy followed by continued treatment with Imfinzi alone.
The CHMP of the EMA based its favorable assessment on a specified exploratory subgroup analysis of mismatch repair (MMR) status from the DUO-E Phase III trial, published in the Journal of Clinical Oncology in October 2023.
According to this analysis, pMMR patients in the Lynparza and Imfinzi group showed a 43% reduction in the risk of disease progression or death compared to the control group (median 15.0 months versus 9.7 months, hazard ratio [HR] 0.57; 95% confidence interval [CI] 0.44-0.73). For dMMR patients, results indicated a 58% reduction in the risk of disease progression or death in the Imfinzi group compared to the control group (median not reached versus 7.0 months, HR 0.42; 95% CI 0.22-0.80).
Susan Galbraith, Executive Vice President of Oncology Research and Development at AstraZeneca, expressed that the EU’s recommendation for approval acknowledges the potential of combining Lynparza and Imfinzi to benefit patients with endometrial cancer, particularly those with mismatch repair proficient disease who currently have limited treatment options. She highlighted that if approved, this combination treatment would offer European patients a new therapeutic choice that combines PARP inhibition with immunotherapy, potentially enhancing clinical outcomes.
The safety profiles of both new treatment plans were acceptable, well-received, and generally in line with the established profiles of the individual drugs. Regulatory authorities are currently reviewing submissions for Imfinzi and Lynparza in Japan and other countries, following the results of the DUO-E trial. In the US, Imfinzi combined with chemotherapy has recently gained approval for patients with primary advanced or recurrent endometrial cancer who have dMMR status.
