Dean Y. Li
Executive Vice President and President, Merck Research Laboratories at Merck & Co., Inc.
Thank you, Caroline. Good morning, everyone. I will provide a brief summary of notable achievements in 2021 and then report on progress since the last earnings call. In 2021, we made meaningful advancements across our broader pipeline with approvals for new molecular entities, including VAXNEUVANCE, Verquvo and WELIREG, and an EUA for Molnupiravir. We also made strides in women's cancers with US regulatory approvals for KEYTRUDA in cervical, endometrial and triple-negative breast cancer. In total, we received more than 30 approvals and filed more than 20 NDAs and sBLAs in the United States, EU, Japan and China. In 2022, we look to build on this progress and momentum.
I will now cover notable regulatory milestones and clinical updates for our Molnupiravir, oncology, pneumococcal, HIV and cardiovascular programs. As we enter the third year of the pandemic, the Omicron variant continues to wreak havoc on our communities and healthcare systems. In the United States alone, we are now seeing approximately 2,000 deaths a day. Vaccines and treatment options have the potential to help combat this pandemic.
Since the first authorization for Molnupiravir by the UK in November, we have received authorizations in nine additional countries, including an Emergency Use Authorization in the United States and a special approval for emergency in Japan. In addition, other countries have provided authorizations to our voluntary license holders. Findings from the MOVe-OUT clinical trial published in the New England Journal of Medicine at the end of last year showed Molnupiravir significantly reduced hospitalization or death in adult patients most in danger of progressing to severe disease. Importantly, for physicians and patients, approximately 90% fewer deaths were seen in those taking Molnupiravir. These results reinforce that Molnupiravir can provide an important oral treatment option for certain adults at high risk for severe illnesses.
The Director of the United States CDC has indicated the need to prioritize therapeutic interventions for people with the highest risk of progression, such as those with certain comorbidities. We believe Molnupiravir's low propensity for drug-drug interactions make it a meaningful and important option for appropriate patients with COVID-19 who are receiving treatments for underlying conditions, such as heart disease, hypertension and diabetes, and for those with impaired liver or kidney function, consistent with local recommendations.
To date, this pandemic has consisted of successive waves of SARS-CoV2 variants, most recently, Omicron. Last week, we announced data from multiple independent studies indicating that Molnupiravir is active against the Omicron variant in vitro. Each surge comes with distinct public health and disease characteristics and corresponding treatment and prevention challenges. The potential threat of rapidly emerging variants reinforces the need for treatment options with high barrier to resistance that target evolutionarily conserved aspects of viral biology.
Recognizing the importance of an oral antiviral, we committed to manufacturing Molnupiravir and have it ready for supply to patients within the US upon emergency use authorization. As Caroline noted, we were able to fulfill that promise and ensure delivery of this important treatment. We are working with governments and partners around the globe to stay ahead of the curve and to further Merck's contribution in fighting this pandemic.
Next, we continue to fortify our position in oncology. Several recent milestones highlight our strategy of targeting earlier-stage cancers where there is potential for improved outcomes by reducing risk of recurrence. We received FDA and European Commission approval for KEYTRUDA in the adjuvant setting for renal cell carcinoma and FDA approval for certain stages of melanoma.
In RCC, approval was based on KEYNOTE-564. KEYTRUDA is the first and only immunotherapy treatment option for certain patients at intermediate, high or high risk of recurrence in the adjuvant setting. And in melanoma, the approval was based on KEYNOTE-716 and provides for the adjuvant treatment of patients 12 years and older with stage IIB and IIC disease, following complete resection. Both approvals provide patients with important new options shown to help reduce the risk of recurrence.
Similarly, we recently announced a positive finding from the KEYNOTE-091 or PEARLS study, evaluating KEYTRUDA as adjuvant treatment for patients with stage IB to IIIA non-small cell lung cancer following surgical resection. At an interim analysis, the trial met one of its dual primary endpoint, demonstrating a statistically significant improvement in disease-free survival in all comers when treated with KEYTRUDA compared to placebo. The trial will continue to analyze DFS in patients whose tumors express high levels of PD-L1, the other dual primary endpoint, which did not meet statistical significance at the time of the planned interim analysis, as well as overall survival, a key secondary endpoint.
We are continuing to make progress in women's cancer based on data from the Phase 3 OlympiA trial. The FDA granted priority review for Lynparza for the adjuvant treatment of patients with BRCA-mutated HER2-negative, high-risk early breast cancer, previously treated with chemotherapy, either before or after surgery. We anticipate FDA action during the first quarter of 2022.
Moving to the broader portfolio. The FDA issued a complete response letter for the new drug applications for gefapixant and have requested additional information related to the measurement of efficacy. There were no safety concerns for gefapixant. And we will continue with the FDA to discuss next steps as we look to address the significant unmet need in patients with chronic cough.
In Japan, we are pleased to announce the Ministry of Health, Labor and Welfare approved LYFNUA, the trademark for gefapixant for adults with refractory or unexplained chronic cough. Momentum continues in our pneumococcal disease program, following the US approval in July 2021, the European Commission VAXNEUVANCE in individuals 18 years of age and older in December. Also in December, we announced the FDA granted priority review of our supplemental application for VAXNEUVANCE in the pediatric setting. Importantly, VAXNEUVANCE incorporates serotypes 22F and 33F up and provides robust response on other key disease-causing serotypes, like serotype 3, therefore, offering the potential to prevent additional invasive disease in children. We anticipate regulatory action in the spring of this year.
Merck has a proud legacy of HIV research, and we remain committed to those impacted by this virus. Following the announcement of the FDA clinical hold for ongoing trials evaluating islatravir, we are working to understand the data and the principles of the finding. We believe in the potential of the nucleoside reverse transcriptase and translocation inhibitor mechanism for both the prevention and treatment of HIV. And we intend to share updates in the future.
Looking across our broader pipeline. As Rob noted, in the fourth quarter, we completed the acquisition of Acceleron. Its lead candidate, sotatercept, is an excellent complement to our pipeline and has the potential to provide a novel approach to treating pulmonary arterial hypertension. The integration is proceeding according to plan, and the Phase 3 program is on track. We plan to provide further details on our cardiovascular pipeline at an investor event in the spring.
In closing, 2021 was a tremendous year where we demonstrated our ability to advance both our internal and external pipelines. We are well positioned to continue our momentum into 2022, with a dual focus, becoming the leading oncology company by 2025 and sustaining that position beyond 2028, while also extending our impact across other therapeutic areas. I look forward to providing further updates in the coming year.
Now, I turn the call back to Peter.