The basis of the approval for peginterferon beta-1a was from a phase 1 crossover study that showed the drug’s bioequivalence to subcutaneous injection.
The FDA has approved a new intramuscular (IM) injection route of administration for peginterferon beta-1a (Plegridy; Biogen) for the treatment of relapsing forms of multiple sclerosis (RMS), according to an announcement from the drug developer, Biogen.
Patients will now reap the benefits of the drug, which was originally approved in 2014 as a subcutaneous (SC) injection in patients with RMS, with the potential of significant reduced risk of injection site reactions. It currently stands as the only approved pegylated interferon for MS with a proven ability to delay the progression of MS disability and reduce relapses.
"At Biogen, we are committed to continued innovation to give people with MS more choices and more options to meet their individual preferences and needs,” Maha Radhakrishnan, MD, chief medical officer, Biogen, said in a statement. “PLEGRIDY is a proven, effective therapy for relapsing MS, and this approval gives new and current MS patients a different delivery method that has the potential to significantly reduce injection site reactions.”
The basis of the approval is from a phase 1 crossover study, which evaluated the bioequivalence and adverse reactions associated with IM administration compared to SC administration in health volunteers.
In that study, researchers confirmed the bioequivalence between the 2 dosing regimens and also demonstrated fewer injection site reactions in those taking peginterferon beta-1a (14.4%) compared to those receiving SC administration (32.1%). Notably, the safety profiles were generally similar with no new safety signals observed.
Peginterferon beta-1a is dosed once every 2 weeks for patients with RMS and is currently approved and available in over 60 countries, with over 61,000 people treated worldwide. The drug has proven to significantly reduce the rate of MS relapses, slow the progression of disability and reduce the number of MS brain lesions while demonstrating a well-characterized safety profile for patients with RMS.
Patients who have received the drug through SC administration are subject to side effects that include liver problems, including liver failure and increases in liver enzymes; depression or suicidal thoughts; serious allergic reactions; injection site reactions, cardiac problems, including congestive heart failure; blood problems, such as decreases in white blood cell or platelet counts; autoimmune disorders; and seizures.
Injection site reactions and flu-like symptoms have been the most commonly reported adverse events (AEs) associated with the treatment in clinical trials. Biogen also noted the drug may be considered for use in patients with RMS throughout the full-course of pregnancy and during breast-feeding, if clinically needed.