- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
USFDA pauses initiation of new patients on multiple sclerosis evobrutinib drug: Merck
The company must now place on hold the initiation of new evobrutinib patients and halt studies involving patients who have been taking the drug for less than 70 days.
United States: Merck KGaA said on Wednesday the U.S. Food and Drug Administration (FDA) had paused the initiation of new patients on its multiple sclerosis evobrutinib drug, knocking the German drugmaker's share price.
Merck has been ahead in the race to develop a drug from the class known as Bruton's tyrosine kinase (BTK) inhibitors to slow the progression of nerve disease multiple sclerosis. But tolerability of the class has been a big concern for analysts.
Merck shares were 6.3% lower at 1037 GMT and slid to the bottom of Germany's blue-chip DAX index on news of the setback.
The FDA's decision, Merck said, was in response to laboratory results which suggested drug-induced liver injury during phase III studies. The two cases identified had been asymptomatic and the patients' liver enzymes had fully normalized after discontinuation of the study medication.
"Merck is working closely with the FDA to establish the best path forward for the benefit of patients in current and future trials with evobrutinib," it said in a statement.
The company must now place on hold the initiation of new evobrutinib patients and halt studies involving patients who have been taking the drug for less than 70 days.
The FDA's decision impacts just two patients. Recruitment for a phase III trial was already complete with 2,000 participants and an ongoing study is to continue as planned.
Merck expects to present the first data from that study in the fourth quarter of 2023.
A trial testing Sanofi's rival candidate tolebrutinib - from the $3.7 billion takeover of Principia Biopharma in 2020 - was put on partial hold by the FDA in June 2022 on concerns over harmful effects on the liver. That meant recruitment of new participants was stopped.
Others in the development race are remibrutinib from Novartis and Roche’s fenebrutinib.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751