Sotatercept for Pulmonary Hypertension: Positive Opinion & Class IV Benefits
Redacción Farmacosalud.com
MSD announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an expanded indication for WINREVAIR™ (sotatercept), in combination with other treatments for pulmonary arterial hypertension (PAH), for the treatment of PAH in adults with World Health Institution (WHO) functional class (FC) II, III and IV, based on the Phase III ZENITH study. The currently approved indication in the European Union (EU) is for adults with PAH with WHO FC II to III, to improve exercise capacity. The new suggestion will now be reviewed by the European Commission (EC) to amend the marketing authorization in the EU, Iceland, Liechtenstein and Norway, with a final decision expected in the first quarter of 2026.
“If approved, this broader indication woudl recognize the drug’s impact on morbidity and mortality in adult patients with PAH, expanding the overall treatment use to include patients with WHO FC II, III and now IV, with a therapeutic goal that goes beyond improving exercise capacity,” says Dr.Joerg Koglin, Senior Vice President and Head of General Medicine, Global Clinical Development, of MSD Research Laboratories.
Author: pixdesign123
Source: depositphotos.com
Class IV: shortness of breath or fatigue may occur at rest
According to hipertensión Pulmonar España, Class IV is the most advanced or severe stage of the pathology. That is, there is an inability to carry out any physical activity without experiencing symptoms. Shortness of breath or fatigue may occur at rest.
The CHMP recommendation is based on data from the Phase III ZENITH trial, which showed that adding the drug to background therapy resulted in a statistically significant and clinically relevant 76% reduction in the risk of severe morbidity and mortality, the primary endpoint of the study, in adults with PAH of WHO functional class III or IV compared to placebo (HR: 0.24; 95% CI: 0.13, 0.43; p < 0.0001).The endpoint
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Boeing 737 MAX: Status as of January 15, 2026
Table of Contents
The Boeing 737 MAX, grounded worldwide in March 2019 following two fatal crashes, has undergone extensive scrutiny and modifications. As of January 15, 2026, the aircraft is operating commercially in most global markets, though ongoing quality control concerns and production delays continue to affect deliveries and airline schedules. this report details the current status, recent developments, and related entities.
FAA Oversight of the Boeing 737 MAX
The Federal Aviation Administration (FAA) maintains ongoing oversight of the Boeing 737 MAX, requiring continuous safety improvements and inspections. The FAA lifted the grounding order on December 29, 2020, after Boeing implemented software updates to the Maneuvering Characteristics Augmentation System (MCAS) and provided enhanced pilot training.
Detail: the FAA’s initial review following the crashes identified deficiencies in the MCAS design, pilot training, and Boeing’s safety assessment processes. The subsequent lifting of the grounding order was contingent upon Boeing addressing these issues and demonstrating compliance with new safety standards. The FAA continues to issue Airworthiness Directives (ADs) addressing specific safety concerns.
Example or evidence: On January 8, 2024, the FAA issued Airworthiness Directive 2024-01-08-08 requiring inspections of certain 737 MAX aircraft for potential fastener issues. This directive affects over 1,000 aircraft globally.
Boeing Production and Delivery rates
Boeing is currently aiming for a production rate of 38 737 MAX aircraft per month, but has faced repeated delays due to quality control issues and supply chain disruptions. Deliveries remain below pre-grounding levels.
Detail: Following the grounding and the COVID-19 pandemic, Boeing significantly reduced its 737 MAX production. The company has been working to ramp up production to meet airline demand, but has encountered challenges related to component shortages, manufacturing defects, and increased FAA scrutiny. In December 2023, Boeing announced a voluntary inspection of all 737 MAX aircraft to check for improperly installed rivets.
Example or Evidence: Boeing reported delivering 376 737 MAX aircraft in 2023, according to their Year-End Deliveries Report. This is an increase from 2022, but still below the company’s initial target of 400 deliveries.
Investigations into the 2018 and 2019 Crashes
The National Transportation Safety Board (NTSB) completed its investigation into the Lion Air Flight 610 (October 29, 2018) and Ethiopian Airlines Flight 302 (March 10, 2019) crashes, both involving 737 MAX aircraft. The NTSB’s final report, released in March 2021, cited deficiencies in the design and certification of the MCAS system as a major contributing factor.
Detail: The NTSB investigation revealed that Boeing failed to adequately account for human factors in the design of the MCAS system, and that the FAA’s certification process did not adequately identify these deficiencies.The crashes resulted in the deaths of 346 people.
Example or Evidence: The NTSB’s final report, AM19FG012-FinalReport.pdf, details the sequence of events leading to the crashes and provides recommendations for improving aviation safety.
legal settlements and Liabilities
Boeing has reached settlements with the families of victims of the 737 MAX crashes and has paid billions of dollars in fines and