Tibsovo Approval Makes Agios’ Second AML Approval In A Year; Priced At $26k For 30 Days

Tibsovo is the second targeted therapy approved for a mutation-specific subset of relapsed/refractory AML patients. Agios discovered and jointly markets the first, Idhifa, with Celgene.

Cancer cells on scientific background.3d illustration

Agios Pharmaceuticals Inc. obtained its second approval for a targeted acute myelogenous leukemia drug in less than a year and will soon launch Tibsovo (ivosidenib) for relapsed or refractory AML patients who test positive for an IDH1 mutation. The firm said on July 20 that it set a 30-day wholesale acquisition cost of $26,115 for the drug at a daily dose of 500 mg.

Cambridge, Mass.-based Agios and partner Celgene Corp. won US FDA approval of Idhifa (enasidenib) for the treatment of relapsed or refractory AML patients with an IDH2 mutation in August of last year; that drug launched at $24,872 per month. (Also see "Celgene, Agios Ready For Enasidenib Launch After Early Approval" - Scrip, 1 August, 2017

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Verastem Wins Approval For Novel Drug Combo In Rare Ovarian Cancer

 

The novel RAF/MEK inhibitor and FAK inhibitor are the first treatment approved specifically for KRAS-mutated recurrent low-grade serious ovarian cancer (LGSOC).

Pipeline Watch: Thirteen Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 

The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

More from Scrip

Q1 S&E In Brief: Tracking New Launches And Catalysts In Biopharma

 

Neurocrine, Madrigal and Vanda updated investors on new drug launches, while Cytokinetics talked to investors about an FDA extension for aficamten.

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.

Building Up US Biopharma Manufacturing Will Require Investments In Talent

 

Workforce development will be essential to meeting president Trump’s goal to return biopharma manufacturing to the US.