KENILWORTH, NJ, USA I November 23, 2020 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the company has submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for licensure of V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older. The company awaits acceptance of the submissions by the U.S. and European regulatory authorities.
“For more than a century, Merck inventors have developed vaccines that help tackle some of society’s biggest public health challenges, and that heritage is reflected today in our pneumococcal vaccine portfolio,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These submissions for V114 help bring us closer to offering more options to help protect against pneumococcal disease.”
The regulatory applications for licensure of V114 include results from Phase 2 and Phase 3 clinical studies in a variety of adult populations, including healthy adults and those at increased risk, such as adults with chronic medical conditions, adults with HIV, and those 65 years of age and older.
About V114
V114 is Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate for the prevention of pneumococcal disease in adults and children. V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease in older adults worldwide and are not contained in the pneumococcal conjugate vaccine currently licensed for use in adults. An overview of the late-stage development program for V114 is available here.
V114 previously received Breakthrough Therapy Designation from the FDA for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks to 18 years of age and adults 18 years of age and older.
Merck’s Commitment to Infectious Diseases
For more than 100 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases. In addition to a combined portfolio of vaccines and antibacterial, antiviral and antifungal medicines, Merck has multiple programs that span discovery through late-stage development. To learn more about Merck’s infectious diseases pipeline, visit www.merck.com.
About Merck
For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
Post Views: 74
KENILWORTH, NJ, USA I November 23, 2020 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the company has submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for licensure of V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older. The company awaits acceptance of the submissions by the U.S. and European regulatory authorities.
“For more than a century, Merck inventors have developed vaccines that help tackle some of society’s biggest public health challenges, and that heritage is reflected today in our pneumococcal vaccine portfolio,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These submissions for V114 help bring us closer to offering more options to help protect against pneumococcal disease.”
The regulatory applications for licensure of V114 include results from Phase 2 and Phase 3 clinical studies in a variety of adult populations, including healthy adults and those at increased risk, such as adults with chronic medical conditions, adults with HIV, and those 65 years of age and older.
About V114
V114 is Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate for the prevention of pneumococcal disease in adults and children. V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease in older adults worldwide and are not contained in the pneumococcal conjugate vaccine currently licensed for use in adults. An overview of the late-stage development program for V114 is available here.
V114 previously received Breakthrough Therapy Designation from the FDA for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks to 18 years of age and adults 18 years of age and older.
Merck’s Commitment to Infectious Diseases
For more than 100 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases. In addition to a combined portfolio of vaccines and antibacterial, antiviral and antifungal medicines, Merck has multiple programs that span discovery through late-stage development. To learn more about Merck’s infectious diseases pipeline, visit www.merck.com.
About Merck
For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
Post Views: 74
