The U.S. Food and Drug Administration approved Lundbeck A/S' migraine prevention therapy, which the Danish drugmaker acquired through its near $2 billion deal for Alder BioPharmaceuticals in 2019, the company said on Friday.
For Lundbeck, the approval opens doors to a lucrative but competitive market dominated by already approved rivals from Amgen Inc, Teva Pharmaceutical Industries Ltd and Eli Lilly and Co.
Lundbeck's Vyepti belongs to a class of drugs called monoclonal antibodies (mAb) that are laboratory-produced molecules engineered to serve as substitute disease-fighting antibodies.
Vyepti, also known as eptinezumab, inhibits calcitonin gene-related peptide (CGRP), which plays a key role in causing migraine pain.
Eptinezumab is administered through a 30-minute IV infusion.
The top three leading CGRP inhibitors from Amgen Inc, Eli Lilly & Co and Teva Pharmaceuticals Industries Ltd are all administered by injections.
Amgen's therapy was the first to be approved for the U.S. market in May 2018, but rival Lilly has fought to gain more favorable insurance coverage by offering discounts.
The drug would also be competing with Allergan Plc's Botox, which is a migraine therapy, besides being a blockbuster anti-wrinkle injection.
As Lundbeck enters the crowded market, it hopes to carve a niche for itself through its dosing frequency - quarterly, instead of monthly like most of the CGRP inhibitors. Teva's Ajovy can also be given to patients through a triple dose administered quarterly.
As the drug will be administered at medical facilities, doctors overseeing the process will receive a procedure fee, said SVB Leerink analyst Marc Goodman. This could give eptinezumab an edge over its rivals as it provides an incentive to doctors, Goodman added. Currently, doctors administering Botox receive a procedure fee.
Lundbeck is conducting a late-stage study to support the drug's faster acting profile, with results expected later in the year.
Goodman estimates eptinezumab will be priced at $2,000 per year and forecasts sales of $700 million by 2030 in the United States.
(Reporting by Manas Mishra and Mrinalika Roy in Bengaluru; Additional reporting by Akshay Balan and Abhishek Manikandan in Bengaluru; Editing by Shinjini Ganguli and Sandra Maler)
