PFIZER INC
For the period ended Dec 31, 2023. Filed Feb 22, 2024.
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FY2023 · Filed Feb 22, 2024
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Product Developments
A comprehensive update of Pfizer’s development pipeline was published as of January 30, 2024 and is available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of our research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.
This section provides information as of the date of this filing about significant marketing application-related regulatory actions by, and filings pending with, the FDA and regulatory authorities in the EU and Japan.
The tables below include filing and approval milestones for products that have occurred in the last twelve months and generally do not include approvals that may have occurred prior to that time. The tables include filings with regulatory decisions pending (even if the filing occurred outside of the last twelve-month period).
COVID-19 Vaccine Products
Beginning with the original monovalent Pfizer-BioNTech COVID-19 Vaccine, initially authorized for emergency use, to Comirnaty (COVID-19 Vaccine, mRNA, 2023-2024 Formula), approved by the FDA for individuals 12 years and older and the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) authorized by the FDA for emergency use for individuals 6 months through 11 years of age, efforts to stay current with circulating COVID-19 strains have resulted in the rapid development of targeted, adapted vaccines for licensure in the U.S., Europe, Japan and other markets. The adapted vaccines have included two bivalent formulations (Original and Omicron BA.1, not authorized in the U.S., and Original and Omicron BA.4/BA.5). As updated COVID-19 vaccines are formulated to more closely target currently circulating vaccines, prior vaccine formulations are generally no longer utilized in a majority of the markets.
The 2023-2024 Formula includes a monovalent (single) component that corresponds to the Omicron sub-variant XBB.1.5 of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The table below summarizes the approval of the 2023-2024 Formula in the markets indicated:
| PRODUCT | INDICATION | REGULATORY STATUS | ||
|---|---|---|---|---|
| U.S.(a) | EU | JAPAN | ||
| Comirnaty(COVID-19 Vaccine,mRNA, 2023-2024 Formula) | Active immunization to prevent COVID-19 caused by SARS-CoV-2 for individuals 6 months through 4 years of age | AuthorizedSeptember2023 | ApprovedAugust 2023 | ApprovedSeptember2023 |
| Active immunization to prevent COVID-19 caused by SARS-CoV-2 for individuals 5 through 11 years of age | AuthorizedSeptember2023 | ApprovedAugust 2023 | ApprovedSeptember2023 | |
| Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older | ApprovedSeptember2023 | ApprovedAugust 2023 | ApprovedSeptember2023 | |
(a)In September 2023, Pfizer and BioNTech announced the FDA approved a regulatory application for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 12 years of age and older (Comirnaty (COVID-19 Vaccine, mRNA, 2023-2024 Formula)). The FDA also granted EUA for the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)).
Other Products
| PRODUCT | INDICATION OR PROPOSED INDICATION | APPROVED/FILED* | ||
|---|---|---|---|---|
| U.S. | EU | JAPAN | ||
| Ngenla(somatrogon)(a) | Pediatric growth hormone deficiency | ApprovedJune2023 | ApprovedFebruary2022 | ApprovedJanuary2022 |
| Prevnar 20/Apexxnar(Vaccine) | Active immunization to prevent pneumonia, invasive disease and otitis media caused by Streptococcus pneumoniae (adults) | ApprovedJune2021 | ApprovedFebruary2022 | FiledSeptember2023 |
| Active immunization to prevent pneumonia, invasive disease and otitis media caused by Streptococcus pneumoniae (pediatric) | ApprovedApril2023 | FiledNovember2022 | FiledMarch2023 | |
| TicoVac(Vaccine) | Active immunization to prevent tick-borne encephalitis disease | ApprovedAugust 2021 | FiledMarch2023 | |
| Paxlovid(b) (nirmatrelvir and ritonavir) | COVID-19 in high-risk adults | ApprovedMay2023 | Approved February2023 | Approved July 2023 |
| Nurtec ODT/Vydura(rimegepant) | Acute treatment of migraine with or without aura (adults) | ApprovedFebruary2020 | Approved April 2022 | |
| Prevention of episodic migraine (adults) | ApprovedMay2021 | Approved April 2022 | ||
| Litfulo/Ritfulo(ritlecitinib) | Alopecia areata | ApprovedJune2023 | ApprovedSeptember2023 | ApprovedJune2023 |
| Zavzpret (zavegepant)(intranasal) | Acute treatment of migraine with or without aura (adults) | ApprovedMarch2023 | ||
| Penbraya (PF-06886992)(Vaccine) | Active immunization to prevent serogroups ABCWY meningococcal infections (adolescent and young adults) | ApprovedOctober2023 | FiledJune2023 | |
| Abrysvo(Vaccine) | Active immunization to prevent RSV infection (maternal) | ApprovedAugust2023 | ApprovedAugust2023 | ApprovedJanuary2024 |
| Active immunization to prevent RSV infection (older adults) | ApprovedMay2023 | ApprovedAugust2023 | FiledMay2023 | |
| Velsipity (etrasimod) | Ulcerative colitis (moderately to severely active) | ApprovedOctober2023 | ApprovedFebruary2024 | |
| Braftovi (encorafenib) and Mektovi (binimetinib) | BRAFV600E-mutant metastatic non-small cell lung cancer | ApprovedOctober2023 | FiledOctober2023(c) | |
| Elrexfio (elranatamab) | Multiple myeloma triple-class relapsed/refractory | ApprovedAugust2023 | ApprovedDecember2023 | FiledJune2023 |
| Talzenna (talazoparib) | Combination with Xtandi (enzalutamide) for adult patients with homologous recombination repair (HRR) gene-mutated mCRPC(d) | ApprovedJune2023 | ApprovedJanuary2024 | ApprovedJanuary2024 |
| Treatment of BRCA gene-mutated, HER2-negative, inoperable or recurrent breast cancer who have been treated with cancer chemotherapy | ApprovedOctober2018 | ApprovedJune2019 | ApprovedJanuary2024 | |
| fidanacogene elaparvovec (PF-06838435)(e) | Hemophilia B (adults) | FiledJune2023 | FiledMay2023 | |
| Xtandi (enzalutamide)(f) | nmCSPC with biochemical recurrence at high risk for metastasis (high-risk BCR) | ApprovedNovember2023 | FiledSeptember2023 | |
| marstacimab (PF-06741086) | Hemophilia A and B | FiledDecember 2023 | FiledOctober2023 | |
| aztreonam-avibactam(g)(PF-06947387) | Treatment of infections caused by Gram-negative bacteria with limited or no treatment options | FiledSeptember2023 | ||
| Padcev (enfortumab vedotin-ejfv)(h) | In combination with Keytruda(i) (pembrolizumab) for locally advanced or metastatic urothelial cancer (adults) | ApprovedDecember2023 | FiledJanuary2024 | FiledJanuary2024 |
| Tivdak (tisotumab vedotin-tftv)(j) | Recurrent or metastatic cervical cancer with disease progression on or after first-line therapy | Filed(k)January2024 | FiledFebruary2024 | |
| Tukysa (tucatinib) | In combination with trastuzumab for HER2-positive metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy | ApprovedJanuary2023 | ||
*For the U.S., the filing date is the date on which the FDA accepted our submission. For the EU, the filing date is the date on which the EMA validated our submission.
(a)Being developed in collaboration with OPKO.
(b)Previously authorized under EUA in the U.S. (December 2021) and approved by the FDA in high-risk adults (May 2023). Remains under EUA for children (12-18 years of age; >88lbs) in the U.S.
(c)Pierre Fabre is the Marketing Authorization Holder for Braftovi (encorafenib) and Mektovi (binimetinib) in the EU.
(d)Listed indication applies to U.S. only. EU indication (all comers): mCRPC in whom chemotherapy is not clinically indicated; Japan indication: BRCA gene-mutated mCRPC.
(e)Being developed in collaboration with Spark Therapeutics, Inc.
(f)Being developed in collaboration with Astellas.
(g)Being developed in collaboration with AbbVie. AbbVie has the exclusive commercialization rights to this investigative therapy in the U.S. and Canada; Pfizer leads the joint development program and has commercialization rights in all other countries.
(h)Being developed in collaboration with Astellas.
(i)Keytruda is a registered trademark of Merck Sharp & Dohme Corp.
(j)Being developed in collaboration with Genmab.
(k)January 2024 filing date refers to application for conversion from accelerated to full approval.
The following provides information about additional indications and new drug candidates in late-stage development:
| PRODUCT/CANDIDATE | PROPOSED DISEASE AREA | ||
| LATE-STAGE CLINICAL PROGRAMS FOR ADDITIONAL USES AND DOSAGE FORMSFOR IN-LINE AND IN-REGISTRATION PRODUCTS | Ibrance (palbociclib)(a) | ER+/HER2+ metastatic breast cancer | |
|---|---|---|---|
| Talzenna (talazoparib) | Combination with Xtandi (enzalutamide) for DNA Damage Repair-deficient mCSPC | ||
| Ngenla (somatrogon)(b) | Adult growth hormone deficiency | ||
| Braftovi (encorafenib) and Erbitux® (cetuximab)(c) | First-line BRAFV600E-mutant mCRC | ||
| Paxlovid (nirmatrelvir; ritonavir) | COVID-19 in high-risk children (6-11 years of age; >88lbs) | ||
| Litfulo (ritlecitinib) | Vitiligo | ||
| Elrexfio (elranatamab) | Multiple myeloma double-class exposed | ||
| Newly diagnosed multiple myeloma post-transplant maintenance | |||
| Newly diagnosed multiple myeloma transplant-ineligible | |||
| Oxbryta (voxelotor) | Sickle cell disease (pediatric) | ||
| Eliquis (apixaban)(d) | Venous thromboembolism (pediatric) | ||
| Abrysvo (vaccine) | Active immunization to prevent RSV infection in adults (18-59) | ||
| Padcev (enfortumab vedotin)(e) | Cisplatin-ineligible/decline muscle-invasive bladder cancer | ||
| Cisplatin-eligible muscle-invasive bladder cancer | |||
| Tukysa (tucatinib) | HER2+ adjuvant breast cancer | ||
| 2nd line/3rd line HER2+ metastatic breast cancer | |||
| 1st line HER2+ metastatic colorectal cancer | |||
| NEW DRUG CANDIDATES IN LATE-STAGE DEVELOPMENT | giroctocogene fitelparvovec (PF-07055480)(f) | Hemophilia A | |
| PF-06425090 (Vaccine) | Immunization to prevent primary clostridioides difficile infection | ||
| sasanlimab (PF-06801591) | Combination with Bacillus Calmette-Guerin for non-muscle-invasive bladder cancer | ||
| fordadistrogene movaparvovec (PF-06939926) | Duchenne muscular dystrophy (ambulatory) | ||
| VLA15 (PF-07307405) vaccine(g) | Immunization to prevent Lyme disease | ||
| PF-07252220 (quadrivalent mRNA-based vaccine) | Immunization to prevent influenza | ||
| Vepdegestrant (PF-07850327)(h) | Breast cancer metastatic - 2nd line ER+/HER2- | ||
| inclacumab (PF-07940370) | Sickle cell disease | ||
| Ibrance + vepdegestrant(h) | ER+/HER2- metastatic breast cancer | ||
| Dazukibart (PF-06823859) | Dermatomyositis, polymyositis | ||
| Disitamab vedotin(i) | 1st line HER2 (≥IHC1+) metastatic urothelial cancer | ||
| PF-07926307 (COVID/flu combo vaccine)(j) | Immunization to prevent COVID infection and influenza | ||
| sisunatovir (PF-07923568) | Respiratory syncytial virus infection (adults) | ||
Note: Braftovi/Mektovi/Keytruda previously listed as a late-stage clinical candidate is no longer considered registrational and has been removed.
Note: Zavzpret oral for the prevention of chronic migraine previously listed as a late-stage clinical candidate has been removed.
(a)Being developed in collaboration with The Alliance Foundation Trials, LLC.
(b)Being developed in collaboration with OPKO.
(c)Erbitux is a registered trademark of ImClone LLC. In the EU, we are developing in collaboration with the Pierre Fabre Group. In Japan, we are developing in collaboration with Ono.
(d)Being developed in collaboration with BMS.
(e)Being developed in collaboration with Astellas.
(f)Being developed in collaboration with Sangamo Therapeutics, Inc.
(g)Being developed in collaboration with Valneva.
(h)Vepdegestrant is being developed in collaboration with Arvinas.
(i)Being developed in collaboration with RemeGen Co., Ltd.
(j)Being developed in collaboration with BioNTech.
For additional information about our R&D organization, see Note 17 and the Item 1. Business—Research and Development section. For additional information regarding certain collaboration arrangements, see Item 1. Business—Collaboration and Co-Promotion Agreements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.