Lundbeck’s new migraine drug, Vyepti, is FDA approved
… Lundbeck prepares to launch a new migraine therapy product Vyepti …


Vyepti from Lundbeck competes in a therapeutic sector where managed care contracting and market access strategy with MCOs and PBMs will be critical for it to be successful

John G. Baresky

Lundbeck (OTCMKTS: HLUYY) has announced the FDA approval of its new migraine therapy drug Vyepti (eptinezumab-jjmr) for the preventive treatment of migraine headaches in adults. The product came from the pipeline of Alder Pharmaceuticals which Lundbeck acquired for approximately $2 billion in 2019.

It is estimated over 29 million Americans suffer from migraine headaches. About 75% of patients experiencing migraines are women.

The recommended dose of Vyepti is 100 mg every 3 months. It is noted some patients may benefit from a dose of 300 mg. The product is a humanized monoclonal antibody (mAb) that binds to a protein called calcitonin gene-related peptide (CGRP) and blocks it from the receptor thus preventing it from taking action in the body.

Lundbeck will have to prove itself up to the challenge of competing against pharmaceutical heavyweights in the migraine sector. These rivals already have FDA-approved migraine therapies holding strong formulary positions with MCOs and PBMs through solid managed care market access strategies.

Vyepti is administered via IV infusion whereas many of its competitors have products that are administered by self-injection or other more convenient and potentially less costly methods.

They include:

  • Aimovig (erenumab aooe) is a calcitonin gene-related peptide antagonist (mAb) administered by injection for prevention of migraine from Amgen / Novartis
  • Ajovy (fremanezumab-vfrm) is a calcitonin gene-related peptide antagonist (mAb) administered by injection for the prevention of migraine from Teva
  • Emgality (galcaneuzmab gnlm) is a calcitonin gene-related peptide (CGRP) antibody (mAb) administered by injection for prevention of migraine from Eli Lilly
  • Onzetra Xsail (sumatriptan) is a serotonin (5-HT)1B/1D receptor agonist (triptan) administered by nasal powder from Avanir Pharmaceuticals
  • Reyvow (lasmiditan) is a serotonin (5-HT)1F receptor agonist (ditan) administered by tablet for acute migraine treatment by Eli Lilly
  • Tosymra (sumatriptan) is a serotonin (5-HT)1B/1D receptor agonist (triptan) administered by nasal spray for acute migraine treatment by Dr. Reddy’s Laboratories
  • Ubrelvy (ubrogepant) is a CGRP receptor antagonist in tablet form for acute migraine treatment from Allergan
  • Zembrace SymTouch (sumatriptan) is serotonin (5-HT)1B/1D receptor agonist (triptan) administered by injection by Dr. Reddy’s Laboratories

Lundbeck expects Vyepti to be available to prescribing physicians and patients in April 2020.

Based in Copenhagen, Denmark with a U.S. headquarters located in Deerfield, Illinois (a Chicago suburb) Lundbeck generates about $2.8 billion in annuals sales. It employs roughly 5,000 workers and focuses on brain and psychiatric pharmaceutical therapies.

Lundbeck’s highly specialized product portfolio includes these therapies:

  • Abilify (aripiprazole)
  • Northera (droxidopa)
  • Onfi (clobazam)
  • Rexulti (brexpiprazole)
  • Sabril (vigabatrin)
  • Trintellix (vortioxetine)
  • Xenazine (tetrabenazine)

The Alder acquisition has several promising therapies in its pipeline. Lundbeck is fortunate that it can capitalize on one of them quickly to help pay for the deal and bring value to patients experiencing migraines and the clinicians caring for them.

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