Amerikaanse FDA accepteert wettelijke indiening voor Tanezumab, een mogelijke eersteklasbehandeling voor patiënten met chronische pijn als gevolg van matige tot ernstige artros

Amerikaanse FDA accepteert wettelijke indiening voor Tanezumab, een mogelijke eersteklasbehandeling voor patiënten met chronische pijn als gevolg van matige tot ernstige artros

maart 3, 2020 0 Door admin

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NEW YORK and INDIANAPOLIS, March 2, 2020 /PRNewswire/ — Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for tanezumab 2.5 mg administered subcutaneously (SC), which is being evaluated for patients with chronic pain due to moderate-to-severe osteoarthritis (OA) who have experienced inadequate pain relief with other analgesics. Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors.” data-reactid=”12″ type=”text”>NEW YORK and INDIANAPOLIS, March 2, 2020 /PRNewswire/ — Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for tanezumab 2.5 mg administered subcutaneously (SC), which is being evaluated for patients with chronic pain due to moderate-to-severe osteoarthritis (OA) who have experienced inadequate pain relief with other analgesics. Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors.

December 2020. In its acceptance letter, the FDA stated that it is currently planning to hold an Advisory Committee meeting to discuss this application.” data-reactid=”13″ type=”text”>More than 27 million Americans are living with OA, 11 million of whom have moderate-to-severe OA. Currently available treatment options for moderate-to-severe OA do not meet the needs of all patients, and many cycle through multiple therapies to find relief from their pain. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA to make a decision on the tanezumab application is in December 2020. In its acceptance letter, the FDA stated that it is currently planning to hold an Advisory Committee meeting to discuss this application.

Ken Verburg, tanezumab development team leader, Pfizer Global Product Development. “There is an urgent need for innovation in the treatment of osteoarthritis, as there have been no new classes of medicines available for this debilitating condition in more than a decade. If approved, tanezumab would be a first-in-class treatment for patients suffering from chronic pain due to moderate-to-severe osteoarthritis who have experienced inadequate pain relief with other analgesics.”” data-reactid=”14″ type=”text”>”The FDA acceptance of the tanezumab application represents a significant milestone, and the breadth of our regulatory submission reflects the extensive clinical data we have gathered for tanezumab over the course of its development,” said Ken Verburg, tanezumab development team leader, Pfizer Global Product Development. “There is an urgent need for innovation in the treatment of osteoarthritis, as there have been no new classes of medicines available for this debilitating condition in more than a decade. If approved, tanezumab would be a first-in-class treatment for patients suffering from chronic pain due to moderate-to-severe osteoarthritis who have experienced inadequate pain relief with other analgesics.”

Patrik Jonsson, president, Lilly Bio-Medicines. “We look forward to working closely with the FDA to potentially bring tanezumab to patients living with moderate-to-severe osteoarthritis.”” data-reactid=”15″ type=”text”>”Osteoarthritis patients face a significant burden – due to the physical pain they experience, nearly every aspect of their lives can be impacted. This pain can affect their ability to participate in daily activities, which can have significant psychological, social and societal consequences,” said Patrik Jonsson, president, Lilly Bio-Medicines. “We look forward to working closely with the FDA to potentially bring tanezumab to patients living with moderate-to-severe osteoarthritis.”

The tanezumab regulatory submission encompasses data from 39 Phase 1-3 clinical studies evaluating the safety and efficacy of tanezumab among more than 18,000 patients, including three Phase 3 studies evaluating SC administration of tanezumab in patients with moderate-to-severe OA.

The Pfizer-Lilly Alliance
In 2013, Pfizer and Lilly entered into a worldwide collaboration to develop and commercialize tanezumab, a monoclonal antibody that is part of an investigational class of non-opioid pain medications known as NGF inhibitors. Tanezumab has the potential to address significant unmet needs in moderate-to-severe OA, a condition that can have life-altering physical, social, psychological and economic impacts. We are driven by our shared mission to improve the lives of the millions of people who are suffering from chronic pain. Together, we are leveraging our deep clinical expertise with the goal of delivering scientific innovation in chronic pain management and making a meaningful difference for people around the world.” data-reactid=”18″ type=”text”>The Pfizer-Lilly Alliance
In 2013, Pfizer and Lilly entered into a worldwide collaboration to develop and commercialize tanezumab, a monoclonal antibody that is part of an investigational class of non-opioid pain medications known as NGF inhibitors. Tanezumab has the potential to address significant unmet needs in moderate-to-severe OA, a condition that can have life-altering physical, social, psychological and economic impacts. We are driven by our shared mission to improve the lives of the millions of people who are suffering from chronic pain. Together, we are leveraging our deep clinical expertise with the goal of delivering scientific innovation in chronic pain management and making a meaningful difference for people around the world.

www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_NewsLinkedInYouTube and like us on Facebook at Facebook.com/Pfizer.” data-reactid=”19″ type=”text”>Pfizer Inc.: Breakthroughs that change patients’ lives
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, including innovative medicines and vaccines. 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_NewsLinkedInYouTube and like us on Facebook at Facebook.com/Pfizer.

www.lilly.com and lilly.com/newsroom. P-LLY” data-reactid=”24″ type=”text”>About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and lilly.com/newsroom. P-LLY

March 2, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.” data-reactid=”25″ type=”text”>PFIZER DISCLOSURE NOTICE: The information contained in this release is as of March 2, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended www.sec.gov and www.pfizer.com.” data-reactid=”27″ type=”text”>A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Pfizer Media Contact:                      

Eli Lilly Media Contact:

Steve Danehy                                   

Jen Dial

212-733-1538                                    

317-220-1172

steven.danehy@pfizer.com                 

dial_jennifer_kay@lilly.com 

Pfizer Investor Contact:                    

Eli Lilly Investor Contact:

Ryan Crowe                                       

Kevin Hern

212-733-8160                                      

317-277-1838

Ryan.Crowe@pfizer.com                       

hern_kevin_r@lilly.com    

Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

Cision

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SOURCE Eli Lilly and Company

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