USFDA approves Danish drugmaker Lundbeck's migraine prevention therapy

The US 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, Teva Pharmaceutical Industries 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, Eli Lilly & Co and Teva Pharmaceuticals Industries are all administered by injections. Amgen’s therapy was the first to be approved for the US market in May 2018, but rival Lilly has fought to gain more favourable insurance coverage by offering discounts.

The drug would also be competing with Allergan’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.