MRK News & Events

Merck announced that the U.S. FDA has approved an expanded indication for Capvaxive to include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. With this approval, Capvaxive is the only PCV specifically indicated and studied in the U.S. for use in this patient population.

RBC Capital analyst Trung Huynh tells investors in a research note that CMS on Friday proposed making the Medicare Drug Price Negotiation Program permanent beginning in 2029 and tightening rules around fixed-combination lifecycle strategies, creating headline risk for Johnson & Johnson (JNJ), Bristol Myers Squibb (BMY), Merck (MRK), and Regeneron (REGN), although legal challenges, statutory exemptions, and portfolio diversification are expected to limit the practical impact.

A new proposal from the Centers for Medicare & Medicaid Services would establish a permanent framework for the Medicare Drug Price Negotiation Program, creating a more transparent and sustainable process for lowering drug costs for millions of Medicare beneficiaries. The proposed rule would also create greater long-term certainty for drug manufacturers that participate in negotiations. It includes policies for negotiating and renegotiating high-cost, single-source drugs beginning with initial price applicability year 2029, while continuing to support innovation and strengthen the program. "This proposed rule lowers drug prices for seniors and ensures continued savings," said CMS Administrator Dr. Mehmet Oz. "We are moving from annual updates to a permanent, predictable framework. This approach puts patients first, strengthens Medicare, and protects the innovation pipeline that delivers future cures." CMS will select up to 20 additional negotiation-eligible drugs covered under Part D and/or payable under Part B for this fourth cycle of negotiations and subsequent cycles of the Negotiation Program. As required by law, the Negotiation Program must also transition from being implemented through guidance to being codified in regulations as a durable, long-term framework. This rule also would create certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program. The rule also proposes a narrow modification of the policy used to identify qualifying single source drugs to address potential program integrity concerns posed by certain new formulations. In addition to codifying the existing program, CMS is proposing to implement the Temporary Floor for Small Biotech Drugs, as required by law, which limits CMS from offering or agreeing to a counteroffer for a maximum fair price for Small Biotech Drugs below the floor for certain eligible drugs during initial price applicability years 2029 and 2030. Publicly traded companies in the space include AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).

Merck announced the U.S. Food and Drug Administration approved KEYTRUDA and KEYTRUDA QLEX, Merck's anti-PD-1 therapies, each in combination with WELIREG, Merck's first-in-class, oral hypoxia-inducible factor-2 alpha inhibitor, for the adjuvant treatment of adult patients with renal cell carcinoma with a clear cell component at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. These approvals represent the first approval for WELIREG in earlier-stage ccRCC and the first approvals for PD-1 and HIF-2alpha inhibitor combination regimens. The approvals are based on results from the pivotal Phase 3 LITESPARK-022 trial. LITESPARK-022 enrolled 1,841 patients and demonstrated that KEYTRUDA in combination with WELIREG significantly improved disease-free survival, the trial's primary endpoint, reducing the risk of disease recurrence, metastasis or death by 28% for patients with ccRCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions compared to KEYTRUDA plus placebo. The estimated 24-month DFS rate was 81% with KEYTRUDA plus WELIREG compared to 74% with KEYTRUDA plus placebo. Median DFS was not reached in either arm. Overall survival results were not yet mature at this interim analysis. The effectiveness of KEYTRUDA QLEX for its approved indications has been established based upon evidence from the adequate and well-controlled studies conducted with KEYTRUDA and additional data from MK-3475A-D77 comparing the pharmacokinetic, efficacy, and safety profiles of KEYTRUDA QLEX and KEYTRUDA.