MHRA approval for Byannli
Market authorisation for twice yearly schizophrenia treatment which offers patients much-needed medication continuity. The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation in Britain for the long-acting atypical antipsychotic therapy Byannli–the six-monthly paliperidone palmitate (PP6M)–for the maintenance treatment of schizophrenia in adult patients.
This makes PP6M the first twice-yearly treatment for adults living with schizophrenia to be approved by the MHRA, with the longest available dosing interval for an antipsychotic medication in Britain.
PP6M is a long-acting injectable (LAI) that works by dissolving and entering the bloodstream slowly, resulting in continuous absorption of paliperidone palmitate over a six-month period.
The MHRA authorisation is based on data from the Route 6 Study; a randomised, double-blind phase 3 global study designed to demonstrate that PP6M is not less effective than PP3M for the prevention of relapse in participants who were previously stabilised on a shorter-acting formulation of paliperidone palmitate.
Schizophrenia affects approximately 20 million people worldwide and nearly 300,000 people in the UK. According to the NHS website, symptoms include hallucinations, delusions–unusual beliefs not based on reality–and not caring about one’s personal hygiene.
Antipsychotic medication is an essential component in the treatment of schizophrenia and helps to prevent symptoms and relapse. As nearly 70% of people with schizophrenia do not receive the appropriate care, this highlights the importance of early intervention, in order to improve patient outcomes.
Professor David Taylor, director of Pharmacy and Pathology at the Maudsley Hospital, commented: “Schizophrenia is a chronic and severe brain disorder and antipsychotic medication plays an important role in its treatment. However, many people with the illness experience relapses which are often caused by poor adherence to oral medication.”
He added: “Long-acting injectable treatments can offer better protection against relapse and greater patient convenience compared with oral medication. This authorisation is a major step forward for people living with schizophrenia, providing them with the option of a treatment that needs to be administered only twice a year.”