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Merck KGaA drops BTK inhibitor evobrutinib, marking end of road for blockbuster dreams

2024-03-07

临床3期并购临床结果

Merck is far from the only Big Pharma to have seen a route for BTK inhibitors to tackle MS.

Merckbeen a quick fall from grace for evobrutinib. Only months BTK inhibitors BTK, Merck KGaA was outlining hopes for a major commercialization push for the BTK inhibitor—and now the German pharma has dropped the drug completely.

Merck told Fierce Biotech that the decevobrutinibade in response to Merck KGaAe of evobrutinib to beat Sanofi’s Aubagio in two phase 3 multiplBTKclerosis (MS) clinical trials in December 2023. With Merck having pinned blockbuster hopes on the drug, the pair of failures sent shockwaves through the BTK inhibitor space at the time.

Merckompany revealed the decision to give up on evobrutinib in a fourth-quarter earevobrutinibts presenSanofi, wAubagio described how smultiple sclerosis (MS)with a one-time cost of 95 million eurosMerck3.5 million), which Merck booked for the fourth quarter of 2024. This financial impact was counBTKbalanced by sales momentum and income from the PD-L1 antibody Bavencio, for which Merck re-secured the rights from Pfizer a year ago.

Merck is far from the only Big Pharma to have seevobrutinibl in BTK inhibitors to tackle smoldering MS, chronic inflammation linked to the progression of symptoms in patients who appear to have stable disease. Sanofi made aMercksh in the space by paying $3.7 billion to buy Principia Biopharma in 2020, while Biogen, Novartis and Roche have all takPD-L1 antibodyiBavencioe 2 or 3 cliMerck trials.Pfizer

Merckerck’s December data removed the German company from the raBTK inhibitors BTK Specifically, the annualized relapsechronic inflammationents with relapsing MS were almost identical in recipients of evobrutinib and the contSanofiug, Sanofi’s Aubagio.Principia Biopharma Biogen Novartis Roche

RespMerckg to the results at the time, Merck noted that the ARRs in recipients of Aubagio were lower than those seen in other recent prelapsing MSes of the treatment. The ARR in recipienevobrutinibutinib slipped from theSanofi 2 Aubagiowhen the rate in patients who received 75 mg twice a day was 0.08 at week 24 and 0.11 in a recent long-term analysis. The ARR on the Aubagio label is 0.37; in another phase 3 trial the ARR was 0.29.

Up to the phase 3 readouts, the company had maintained sky-high hopes for the drugAubagiocently as November, Merck had outlined plans to support evobrutinib with a major commercialization pushevobrutinibnvestors that launch preparations would drive up costs starting in the fourth quarter and mulling whether to use a voucher to accelerate the FDA review.Aubagio

On a call with analysts to discuss the earnings results, Merck CEO Belén Garijo admitted the BTK inhibitor’sMerckure “was no doubt a disappointmevobrutinib FDA

“Despite the setback with evobrutinib, we will remain focMerckon stringent execution of our stBTKegies to both drive our existing product portfolio and to continue to increase optionality for our pipeline,” the CEO added.

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机构

Merck KGaA