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

VYEPTI: LUNDBECK’S NEW PREVENTATIVE MIGRAINE THERAPY

New product from Lundbeck competes in the healthcare sector where its contracting and market access strategy with MCOs and PBMs will be critical for it to be successful

John G. Baresky

Lundbeck seeks to capitalize quickly on Alder Pharmaceuticals acquisition

Lundbeck (OTCMKTS: HLUYY) has announced the FDA approval of its new migraine therapy drug Vyepti (eptinezumab-jjmr) for the preventive treatment of migraine in adults. Vyepti is an infused pharmaceutical therapy.

The product came from the pipeline of Alder Pharmaceuticals which Lundbeck acquired for approximately $2 billion in 2019.

Vyepti is the first intravenous (IV) therapy for prevention of migraine headaches

The recommended dose of Vyepti is 100 mg every 3 months and it is noted some patients may benefit from a dose of 300 mg. The product is a humanized monoclonal antibody (mAb) that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

Lundbeck is well known for its brain and psychiatric product focus

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 features:

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

Migraine pharmaceutical therapy market is competitive and crowded

Lundbeck will have to prove itself up to the challenge of competing against pharmaceutical heavyweights in the migraine sector who already have FDA-approved therapies in strong 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 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 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 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.

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