NEW YORK & INDIANAPOLIS–(BUSINESS WIRE) March 25, 2021 — Pfizer Inc. (NYSE:PFE) and Eli Lilly and Firm (NYSE:LLY) right this moment introduced the end result of the U.S. Meals and Drug Administration (FDA) Joint Arthritis Advisory Committee and Drug Security and Danger Administration Advisory Committee on tanezumab. There was a single voting query centered on whether or not the proposed threat analysis and mitigation technique (REMS) for tanezumab will guarantee its advantages outweigh its dangers, and the Committee voted 1 in favor and 19 in opposition to. Tanezumab 2.5 mg administered subcutaneously (SC) each eight weeks is being evaluated for the remedy of moderate-to-severe osteoarthritis (OA) ache in grownup sufferers for whom use of different analgesics is ineffective or not applicable. Tanezumab is an investigational monoclonal antibody in a brand new class of medicines known as nerve development issue (NGF) inhibitors, which work in a unique method than presently obtainable remedies equivalent to opioids, nonsteroidal anti-inflammatory medicine (NSAIDs) and different analgesics. In research so far, tanezumab has not demonstrated a threat of habit, misuse or dependence.
“Whereas we’re disenchanted with right this moment’s consequence, we proceed to consider that tanezumab has a constructive benefit-risk profile for sufferers with moderate-to-severe osteoarthritis ache for whom present remedies are ineffective or not applicable. Many of those sufferers have exhausted obtainable therapies, haven’t had a brand new class of medicines obtainable to them in additional than a decade and are keen for brand spanking new, non-opioid choices,” stated Ken Verburg, tanezumab improvement staff chief, Pfizer World Product Improvement. “We’ll proceed to work with the FDA because the company continues its assessment of our utility.”
The Advisory Committee’s discussions had been based mostly on the Biologics License Utility (BLA) presently below assessment by the FDA. The BLA contains knowledge from 20 Section 1-Three scientific research evaluating the protection and efficacy of tanezumab administered intravenously or SC in sufferers with OA, together with three pivotal Section Three SC research involving greater than 4,500 sufferers with moderate-to-severe OA.
“The dialogue through the open public discussion board of this week’s Advisory Committee assembly bolstered the pressing want for innovation for folks residing with moderate-to-severe osteoarthritis ache – a lot of whom cycle by three to 4 therapies annually with out enough reduction. The unresolved ache can affect all points of their lives, creating bodily, emotional, social and monetary hardships,” stated Ilya Yuffa, president, Lilly Bio-Medicines.
Advisory Committees present the FDA with impartial opinions and proposals from exterior medical specialists through the regulatory assessment course of; nonetheless, the suggestions will not be binding.
“Osteoarthritis is the most typical sort of arthritis and poses distinctive challenges for sufferers,” stated Steven Taylor, govt vice chairman, mission & strategic initiatives for the Arthritis Basis. “Regardless of its far-reaching affect, many sufferers nonetheless dwell with debilitating ache and have exhausted or are unable to take or tolerate presently obtainable therapies. That’s the reason the Arthritis Basis advocates for modern remedy options and a patient-centered strategy to managing power ache for these with osteoarthritis.”
Tanezumab is an investigational monoclonal antibody that works by selectively focusing on, binding to and inhibiting NGF. NGF ranges improve within the physique because of harm, irritation or in power ache states. By inhibiting NGF, tanezumab might assist to maintain ache indicators produced by muscular tissues, pores and skin and organs from reaching the spinal wire and mind. Tanezumab has a novel mechanism that acts within the periphery in a unique method than opioids and different analgesics, together with nonsteroidal anti-inflammatory medicine (NSAIDs), and in research so far, tanezumab has not demonstrated a threat of habit, misuse or dependence.
OA is a power, progressive and disabling illness of the joint that could be a main reason for power ache. In america, OA impacts an estimated 31 million folks, 11 million of whom have moderate-to-severe OA and have been residing with the situation for a median of 9 years. OA locations a big burden on these sufferers – the ache can restrict their capability to operate, which might power compromises in on a regular basis life, negatively impacting their roles and relationships and inflicting emotions of isolation, frustration and anxiousness. OA can even affect their capability to operate within the office. There’s a want for innovation, as presently obtainable remedy choices for moderate-to-severe OA don’t meet the wants of all sufferers.
Concerning the Pfizer-Lilly Alliance
In 2013, Pfizer and Lilly entered right into a collaboration to develop and commercialize tanezumab. If authorized, the businesses will collectively commercialize tanezumab within the U.S. and Pfizer can be liable for commercialization actions exterior of the U.S. Pfizer and Lilly are pushed by our shared mission to enhance the lives of the thousands and thousands of people who find themselves affected by moderate-to-severe OA ache, and collectively, we’re leveraging our deep scientific experience to make a significant distinction for sufferers.
About Pfizer: Breakthroughs That Change Sufferers’ Lives
At Pfizer, we apply science and our world sources to deliver therapies to folks that stretch and considerably enhance their lives. We try to set the usual for high quality, security and worth within the discovery, improvement and manufacture of well being care merchandise, together with modern medicines and vaccines. On daily basis, Pfizer colleagues work throughout developed and rising markets to advance wellness, prevention, remedies and cures that problem probably the most feared ailments of our time. In line with our accountability as one of many world’s premier modern biopharmaceutical firms, we collaborate with well being care suppliers, governments and native communities to assist and broaden entry to dependable, inexpensive well being care all over the world. For greater than 170 years, we’ve labored to make a distinction for all who depend on us. We routinely put up info which may be necessary to buyers on our web site at As well as, to be taught extra, please go to us on and observe us on Twitter at @Pfizer and @Pfizer Information, LinkedIn, YouTube and like us on Fb at
About Eli Lilly and Firm
Lilly is a world well being care chief that unites caring with discovery to create medicines that make life higher for folks all over the world. We had been based greater than a century in the past by a person dedicated to creating high-quality medicines that meet actual wants, and right this moment we stay true to that mission in all our work. Throughout the globe, Lilly workers work to find and convey life-changing medicines to those that want them, enhance the understanding and administration of illness, and provides again to communities by philanthropy and volunteerism. To be taught extra about Lilly, please go to us at and
PFIZER DISCLOSURE NOTICE: The knowledge contained on this launch is as of March 25, 2021. Pfizer assumes no obligation to replace forward-looking statements contained on this launch as the results of new info or future occasions or developments.
This launch comprises forward-looking details about a product candidate, tanezumab and a possible indication within the U.S. for the remedy of moderate-to-severe OA ache in grownup sufferers for whom use of different analgesics is ineffective or not applicable, together with its potential advantages, that includes substantial dangers and uncertainties that would trigger precise outcomes to vary materially from these expressed or implied by such statements. Dangers and uncertainties embrace, amongst different issues, the uncertainties inherent in analysis and improvement, together with the flexibility to fulfill anticipated scientific endpoints, graduation and/or completion dates for our scientific trials, regulatory submission dates, regulatory approval dates and/or launch dates, in addition to the potential for unfavorable new scientific knowledge and additional analyses of current scientific knowledge; the chance that scientific trial knowledge are topic to differing interpretations and assessments by regulatory authorities; whether or not regulatory authorities can be happy with the design of and outcomes from our scientific research; whether or not and when drug purposes for any potential indications for tanezumab could also be filed in some other jurisdictions; whether or not and when the FDA might approve the pending utility for the potential indication and whether or not and when regulatory authorities in any jurisdictions might approve any such different purposes which may be filed for tanezumab, which can rely upon myriad elements, together with making a willpower as as to if the product’s advantages outweigh its identified dangers and willpower of the product’s efficacy and, if authorized, whether or not tanezumab can be commercially profitable; choices by regulatory authorities impacting labeling, manufacturing processes, security and/or different issues that would have an effect on the provision or business potential of tanezumab; uncertainties concerning the affect of COVID-19 on Pfizer’s enterprise, operations and monetary outcomes; and aggressive developments.
An extra description of dangers and uncertainties may be present in Pfizer’s Annual Report on Kind 10-Ok for the fiscal 12 months ended December 31, 2020 and in its subsequent reviews on Kind 10-Q, together with within the sections thereof captioned “Danger Elements” and “Ahead-Trying Info and Elements That Might Have an effect on Future Outcomes”, in addition to in its subsequent reviews on Kind 8-Ok, all of that are filed with the U.S. Securities and Alternate Fee and obtainable at and
LILLY DISCLOSURE NOTICE: This press launch comprises forward-looking statements (as that time period is outlined within the Non-public Securities Litigation Reform Act of 1995) about tanezumab as a possible remedy for sufferers with moderate-to-severe OA ache for whom the usage of different analgesics is ineffective or inappropriate and displays Lilly’s present beliefs and expectations. Nonetheless, as with every pharmaceutical product, there are substantial dangers and uncertainties within the means of analysis, improvement, and commercialization. Amongst different issues, there may be no assure that future examine outcomes can be per the outcomes so far, that tanezumab will obtain regulatory approvals or be commercially profitable. For additional dialogue of those and different dangers and uncertainties, see Lilly’s most up-to-date Kind 10-Ok and Kind 10-Q filings with america Securities and Alternate Fee. Besides as required by regulation, Lilly undertakes no obligation to replace forward-looking statements to mirror occasions after the date of this launch.
Supply: Pfizer Inc.
Posted: March 2021
Tanezumab FDA Approval Historical past