Breakthrough Therapy Designation Designed by FDA to Expedite the Development and Review of Drugs and Vaccines Which May Demonstrate Substantial Improvement Over Available Therapy1
NEW YORK, NY, USA I September 20, 2018 I Pfizer Inc. (NYSE:PFE) announced today that its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older.2 Pfizer expects to start Phase 3 trials in a few months.
The FDA decision is informed by the results of the 20vPnC Phase 2 randomized, double-blind trial to evaluate the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in adults 60 through 64 years of age. Pfizer will seek to present and publish outcomes from this clinical trial at a future date.
“We look forward to continuing our dialogue with the FDA so that we can accelerate the development program of the adult indication of Pfizer’s 20-valent next-generation pneumococcal vaccine candidate,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “There continues to be a global health need to protect against the potentially devastating effects of invasive pneumococcal disease and pneumonia caused by additional serotypes, and we are dedicated to continue to build on our expertise in pneumococcal conjugate vaccines with this vaccine candidate.”
Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).3 Drugs and vaccines that receive Breakthrough Therapy Designation are eligible for all features of the FDA’s Fast Track designation, which may include more frequent communication with the FDA about the drug’s development plan and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.4
The FDA previously granted Fast Track designation for 20vPnC in October 2017 for use in adults aged 18 years and older.5 The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.4
Pfizer Inc: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best‐known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
1 U.S. Food and Drug Administration. https://www.fda.gov/ForPatients/Approvals/Fast/default.htm
2 Data on file. Pfizer Inc., New York, NY.
3 U.S. Food and Drug Administration. Breakthrough Therapy https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm
4 U.S. Food and Drug Administration. Fast Track https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
5 Data on file. Pfizer Inc., New York, NY.
SOURCE: Pfizer
Post Views: 19
Breakthrough Therapy Designation Designed by FDA to Expedite the Development and Review of Drugs and Vaccines Which May Demonstrate Substantial Improvement Over Available Therapy1
NEW YORK, NY, USA I September 20, 2018 I Pfizer Inc. (NYSE:PFE) announced today that its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older.2 Pfizer expects to start Phase 3 trials in a few months.
The FDA decision is informed by the results of the 20vPnC Phase 2 randomized, double-blind trial to evaluate the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in adults 60 through 64 years of age. Pfizer will seek to present and publish outcomes from this clinical trial at a future date.
“We look forward to continuing our dialogue with the FDA so that we can accelerate the development program of the adult indication of Pfizer’s 20-valent next-generation pneumococcal vaccine candidate,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “There continues to be a global health need to protect against the potentially devastating effects of invasive pneumococcal disease and pneumonia caused by additional serotypes, and we are dedicated to continue to build on our expertise in pneumococcal conjugate vaccines with this vaccine candidate.”
Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).3 Drugs and vaccines that receive Breakthrough Therapy Designation are eligible for all features of the FDA’s Fast Track designation, which may include more frequent communication with the FDA about the drug’s development plan and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.4
The FDA previously granted Fast Track designation for 20vPnC in October 2017 for use in adults aged 18 years and older.5 The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.4
Pfizer Inc: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best‐known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
1 U.S. Food and Drug Administration. https://www.fda.gov/ForPatients/Approvals/Fast/default.htm
2 Data on file. Pfizer Inc., New York, NY.
3 U.S. Food and Drug Administration. Breakthrough Therapy https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm
4 U.S. Food and Drug Administration. Fast Track https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
5 Data on file. Pfizer Inc., New York, NY.
SOURCE: Pfizer
Post Views: 19
