Fonte: FirstWord Pharma
Reveja as principais notícias da semana, de acordo com raking da FirstWord Pharma.
Nexletol could get a boost, data show
After an underwhelming first few years on the market, Esperion’s Nexletol (bempedoic acid) will likely see a boost after a recent readout at the American College of Cardiology (ACC) meeting last week. Data from the Phase III CLEAR cardiovascular (CV) outcomes trial of 14,000 patients showed that the cholesterol-reducing drug lowered the risk of major adverse CV events (MACE) by 13% to 15% and reduced the risk of heart attack and coronary revascularisation by 23% and 19%, respectively, versus placebo. Esperion touts Nexletol as the first non-statin to meet the four-point MACE endpoint in a large outcomes study, and aims for FDA approval for an expanded label in the first half of 2024. The company announced Wednesday that the International Lipid Expert Panel recommended use of Nexletol ahead of PCSK9 inhibitors. Cardiologists are also giving it their seal of approval, with 94% and 98% of those responding to a new FirstWord poll stating that they would at least consider prescribing Nexletol for the primary and secondary prevention of CV disease in statin-intolerant patients, respectively.
Merck & Co. scores wins at ACC with hypertension, cholesterol drugs
Data presented at the ACC annual meeting showed promise for two Merck & Co. drug candidates. In a Phase III study, the activin-signaling inhibitor sotatercept demonstrated a 34- to 41-metre improvement in the six minute walk test (6MWT), and the oral PCSK9 inhibitor MK-0616 showed LDL-cholesterol reduction of 41% to 61% at eight weeks in a Phase II study. Sotatercept, a potential treatment for pulmonary arterial hypertension, surpassed the demonstrated efficacy of currently marketed rivals by also showing an 84% reduction in time to death or first non-fatal clinical worsening event. The results exceed benchmarks set by cardiologists who previously provided feedback to FirstWord, and make approval look like a foregone conclusion. MK-0616, having shown efficacy on par with injectable PCSK9 inhibitors, is slated to enter Phase III testing later this year.
Eisai, Biogen seek full approval for Leqembi
After granting accelerated approval to Leqembi in January to help slow down cognitive decline in Alzheimer’s disease patients, the FDA said this week that it plans to convene an advisory panel to discuss the anti-beta amyloid mAb before potentially converting it to a full approval. A decision is expected by July 6, and if it is approved through the FDA’s standard review process, Leqembi could gain broader coverage by the US Centers for Medicare and Medicaid Services. Leqembi launched in the US on January 18 at an annual wholesale acquisition cost of $26,500, and Eisai recently said sales of Leqembi are “ahead of expectations”, though specific revenue figures were not provided. The FDA’s ongoing review is based on data from the Phase III Clarity AD trial, which showed that the drug slowed disease progression by 27% compared with placebo in early Alzheimer’s patients.
Zuranolone dodges FDA AdCom for depression
Biogen and partner Sage Therapeutics announced this week that the FDA does not plan to hold an advisory committee meeting ahead of the August 5 PDUFA date for zuranolone, which is under review to treat major depressive disorder (MDD) and postpartum depression (PPD). A recent FirstWord poll of US psychiatrists and primary care practitioners found that 90% of those surveyed would consider prescribing zuranolone to existing depression patients with unresolved symptoms, but that only 13% viewed it as practice-changing in light of data showing that in some cases, the positive effect of zuranolone diminished by day 14.
FDA’s ODAC gives thumbs up for Polivy
The FDA’s Oncologic Drug Advisory Committee (ODAC) voted 11-2 on Thursday supporting the benefit-risk profile for Roche’s Polivy (polatuzumab vedotin) in first-line LBCL based on outcomes from the POLARIX trial; its PDUFA date is April 12. The anti-CD79b antibody-drug conjugate (ADC) is already approved in the second-line setting in the US and as a frontline agent in the EU. However, in briefing documents unveiled ahead of Thursday’s meeting, FDA scientists raised concerns over the lack of overall survival or complete response data in POLARIX, and highlighted highly variable performance between patient subgroups. The positive advisory committee vote is more in line with the view of KOLs who in prior conversations with FirstWord argued for Polivy’s place in the frontline treatment armamentarium, particularly as a bridge to CAR-T therapy.
