Bristol Myers Squibb, an American pharmaceutical company, has recently received a positive opinion from the European Medicines Agency (EMA) on its new chronic hepatitis C (HCV) treatment, which combines two of its drugs, Daklinza and Sunvepra.
The EMA’s opinion is expected to pave the way for the approval of the new treatment within the European Union.
About chronic hepatitis C
HCV is a viral infection that affects the liver. It is transmitted through the blood of infected people, many of whom are unaware they are infected. HCV can cause chronic liver disease, cirrhosis, and liver cancer.
The World Health Organization estimates that 71 million people worldwide have chronic HCV.
The new treatment
The new treatment developed by Bristol Myers Squibb combines Daklinza, an NS5A inhibitor, and Sunvepra, an NS3/4A protease inhibitor.
The combination of these drugs has been shown to be highly effective in curing HCV infection, with cure rates of up to 100% in some clinical trials. The treatment is also well tolerated by patients, with few side effects.
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Clinical trials
Multiple clinical trials have been conducted on the new treatment, including Phase II and Phase III studies. One of the Phase III studies, dubbed UNITY-2, involved 377 patients with chronic HCV infection.
The study found that 98% of patients who received the Daklinza-Sunvepra combination for 12 weeks achieved sustained virologic response (SVR12), which is defined as undetectable levels of HCV in the blood 12 weeks after the end of treatment.
The potential impact of the new treatment
The approval of the Daklinza-Sunvepra combination by the EMA could have a significant impact on the treatment of chronic HCV in Europe.
The current standard of care for HCV is a combination of interferon and ribavirin, which has significant side effects and is not effective in all patients. The new treatment is expected to be more effective and better tolerated, making it a viable alternative for many patients.
Conclusion
The positive opinion from the EMA on Bristol Myers Squibb’s new chronic HCV treatment is an important milestone in the fight against this viral infection.
The new treatment shows great promise in curing HCV infection, with high cure rates and minimal side effects. If approved, it could significantly improve the treatment options available to HCV patients in Europe.
