1. Scrip
  2. >>New Products

Venclyxto Gets EU Nod – But Won't Be A Humira Replacement For AbbVie Yet

 
• By Lucie Ellis-Taitt

AbbVie and Genentech's chronic lymphocytic leukemia (CLL) drug Venclyxto has been recommended for conditional approval in Europe, but its initial limited patient population and potential reimbursement troubles won't see it replace top-seller Humira as a growth driver for AbbVie.

The EMA's scientific advisory body, the committee for medicinal products for human use (CHMP), has given AbbVie and Genentech (a Roche company) the green light for conditional approval of their jointly developed chronic lymphocytic leukemia (CLL) product, Venclyxto (venetoclax). But both companies will need to carefully position the drug alongside their existing CLL therapies – AbbVie's Imbruvica (ibrutinib) and Roche's Gazyva – to avoid cannibalization of sales.

Furthermore, AbbVie will need to pursue label extensions quickly in CLL if Venclyxto is going to help prevent pending profit losses at the company as lead product

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
Start Free Trial

Already a subscriber?

More from New Products

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

 
• By Jessica Merrill

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

Pipeline Watch: Five Approvals And One Phase III Readout

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.

Merck KGaA Seals SpringWorks Buy

 
• By Kevin Grogan

The German group is paying $3.9bn to get hold of the US firm and its two approved products.

More from Scrip

Copycats Compound Novo’s Wegovy Growth Problems

 
• By Andrew McConaghie

The US FDA has ordered compounders of the Danish firm's obesity drug semaglutide to shut up shop later this month, but competition from Eli Lilly is only increasing.

Stock Watch: Market Optimism Outshines Q1 Currency And Tariff Woes

 
• By Andy Smith

The weak US dollar helped some companies reporting first-quarter results and hindered others reporting in stronger currencies. But even the impacts of currencies and Medicare modernization on first-quarter revenues were overlooked when an end to the trade wars seemed possible.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.