Business, Company, International, Macular disease, Therapies

FDA clears Novartis’ new treatment for nAMD

Novartis has secured US regulatory approval for Beovu, the company’s latest therapy for neovascular age-related macular degeneration (nAMD), following the drug’s comparable results in head-to-head trials with Eylea.

The US Food and Drug Administration (FDA) cleared the Beovu (brolucizumab) intravitreal injection for nAMD treatment on 8 October after the Swiss pharmaceutical company used a priority review voucher to fast-track its application.

The drug is now the third major player in the anti-VEGF market to treat nAMD. It will compete with Roche’s Lucentis, the pioneering anti-VEGF treatment that is also marketed by Novartis in markets outside the US.

It is also set to become the largest rival to Bayer/Regeneron’s Eylea (aflibercept), which has established itself as the market-leading therapy since its launch in 2011. Last year the drug generated US$6.75 billion (AU$9.83 b) in global revenue.

The recommended dose for Beovu is three initial monthly injections, followed by one treatment every 8-12 weeks. Eylea’s recommended regimen is three monthly injections, followed by a treatment every eight weeks thereafter. A treat-and-extend dosing regimen has also been approved, meaning some patients may be eligible for treatments every 12 weeks or more.

Beovu’s FDA approval was based on the results of the Hawk and Harrier clinical trials, in which the drug was compared directly with Eylea.

While Beovu demonstrated non-inferiority versus Eylea in mean change in best-corrected visual acuity at year one, it did show greater reduction in central subfield thickness, and fewer patients had intra-retinal and/or sub-retinal fluid; a key marker of disease activity.

According to Novartis, Beovu is now the first FDA-approved anti-VEGF to offer greater fluid resolution compared with Eylea, while maintaining eligible patients on a three-month dosing interval immediately after an initial three-month loading phase.

“The approval of Beovu delivers on the Novartis commitment to reimagining treatments for patients suffering from serious visual impairment,” Ms Marie-France Tschudin, Novartis Pharmaceuticals president, said.

“The product labels of existing treatments state that they are not as effective when dosed every 12 weeks. Beovu is the first to offer less frequent dosing in the first year of therapy while maintaining its effectiveness. This gives more time for wet AMD patients to focus on what’s important in their lives.”

Novartis has reportedly priced the drug at US$1,850 (AU$2,695) per vial which is equivalent to Eylea’s list price, and below Lucentis’ $2,000 (AU$2910) per vial.

“Doctors in the field have told Novartis they expect to switch patients who are getting suboptimal care from current drugs or those that have to their offices frequently,” FiercePharma reported.

“They also expect to start many new patients on Beovu given clinical data showing the new drug can control the disease with visits once every 12 weeks.”