2024 Biological License Application Supplement Noteworthy Approvals
This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed by date of approval, with the most recent action at the top.
| Tradename/Proper Name | Indication for Use | STN | Manufacturer/ License No. |
Approval Date |
|---|---|---|---|---|
| ABRYSVO Respiratory Syncytial Virus Vaccine |
To revise the indication to include active immunization for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. | 125769/225 | Pfizer Inc. 66 Hudson Blvd East, New York, NY 10001 Lic. # 2001 |
10/22/2024 |
| COMIRNATY COVID-19 Vaccine, mRNA |
To include safety and immunogenicity data from a study in which individuals 18 through 64 years of age received COMIRNATY concomitantly with a seasonal influenza vaccine. | 125742/454 | BioNTech Manufacturing GmbH Pfizer, Inc. 66 Hudson Boulevard East New York, NY 10001 Lic. # 2229 |
10/10/2024 |
| VISTASEAL Fibrin Sealant (Human) |
To expand the indication to include pediatric patients aged < 18 years. | 125640/220 | Instituto Grifols, S.A. Grifols Shared Services North America, Inc. 8368 U.S. Highway 70 West Clayton, NC 27520 Lic. # 1181 |
09/27/2024 |
| HEPLISAV-B Hepatitis B Vaccine (Recombinant), Adjuvanted |
To update Section 8.1 (Pregnancy) of the package insert to include data from study DV2-HBV-28 (HBV-28). | 125428/704 | Dynavax Technologies Corporation 2100 Powell Street, Suite 720 Emeryville, CA 94608 Lic. # 1883 |
09/11/2024 |
| ABRYSVO Respiratory Syncytial Virus Vaccine |
To update the ABRYSVO package insert to include the second efficacy and safety analyses (end of season one) from study C3671013, and seasonal inactivated influenza vaccine co-administration data from study C3671006. | 125769/3 | Pfizer Inc. 66 Hudson Blvd East, New York, NY 10001 Lic. # 2001 |
08/30/2024 |
| ACAM2000 Smallpox and Mpox (Vaccinia) Vaccine, Live |
To include prevention of mpox disease in individuals determined to be at high risk for mpox infection. | 125158/297 | Emergent Product Development Gaithersburg Inc. 3500 N. Martin Luther King Jr. Blvd Lansing, MI 48906-9910 Lic. # 2089 |
08/29/2024 |
| MACI autologous cultured chondrocytes on porcine collagen membrane |
For the addition of arthroscopic delivery of MACI to the U.S. Package Insert (USPI) Section 2, Dosage and Administration. | 125603/576 | Vericel Corporation 64 Sidney Street Cambridge, MA 02139 Lic. # 2010 |
08/23/2024 |
| AREXVY Respiratory Syncytial Virus Vaccine, Adjuvanted |
To include data on the durability of the efficacy of AREXVY against Respiratory Syncytial Virus (RSV) associated lower respiratory tract disease over two RSV seasons following administration of a single dose. | 125775/98 | GlaxoSmithKline Biologicals 14200 Shady Grove Road Rockville, MD 20850-7464 Lic. # 1617 |
08/21/2024 |
| BEXSERO Meningococcal Group B Vaccine |
To include data from the confirmatory clinical study conducted to verify and describe the clinical benefit of BEXSERO. The BEXSERO dosing schedule has been revised in individuals 10 through 25 years of age from two doses administered at 0 and ≥1 month to two doses administered at 0 and 6 months, and to include a three-dose schedule of BEXSERO administered at 0, 1-2, and 6 months for the same age group. | 125546/1058 | GlaxoSmithKline Biologicals 14200 Shady Grove Road Rockville, MD 20850-7464 Lic. # 1617 |
08/19/2024 |
| FIBRYGA Fibrinogen (Human) |
To include the fibrinogen supplementation in bleeding adult and pediatric patients with acquired fibrinogen deficiency indication, and to update the US prescribing information to expand the indication to include fibrinogen supplementation in bleeding adult and pediatric patients with acquired fibrinogen deficiency indication. | 125612/133 | OCTAPHARMA Pharmazeutika Produktionsges.m.b.H. 117 West Century Road Paramus, NJ 07652 Lic. # 1646 |
7/31/2024 |
| PALFORZIA Peanut (Arachis hypogaea) Allergen Powder-dnfp |
To expand the age indication to include patients 1 through 3 years of age with a confirmed diagnosis of peanut allergy. | 125696/247 | Aimmune Therapeutics, Inc. 1007 US Hwy 202/206, Bldg JR2 Bridgewater, NJ 08807 Lic. # 2109 |
7/26/2024 |
| XEMBIFY Immune Globulin Subcutaneous (Human) |
To include: 1) biweekly dosing for Primary Humoral Immunodeficiency (PI) patients 2 years of age and older switching from either an intravenous immune globulin or subcutaneous immune globulin; 2) addition of loading and maintenance dosing for treatment-naïve PI patients 2 years of age and older; 3) an increase to the maximal subcutaneous infusion rate to 35 mL/hour/site for PI patients 10 years of age and older. | 125683/265 | Grifols Therapeutics LLC 8368 US 70 Bus Hwy West Clayton, NC 27520 Lic. # 1871 |
7/18/2024 |
| ELEVIDYS delandistrogene moxeparvovec-rokl |
To expand the approved indication to individuals at least 4 years of age for the treatment of Duchenne muscular dystrophy (DMD) in patients who are ambulatory and have a confirmed mutation in the DMD gene. | 125781/34 | Sarepta Therapeutics, Inc. 215 First Street Cambridge, MA 02142 Lic. # 2308 |
06/20/2024 |
| AREXVY Respiratory Syncytial Virus Vaccine, Adjuvanted |
To include use in individuals 50 through 59 years of age who are at increased risk for Lower Respiratory Tract Disease (LRTD) caused by Respiratory Syncytial Virus (RSV). | 125775/132 | GlaxoSmithKline Biologicals 14200 Shady Grove Road Rockville, MD 20850-7464 Lic. # 1617 |
06/07/2024 |
| BREYANZI lisocabtagene maraleucel |
To add a new indication for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. | 125714/227 | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company P.O. Box 5326 Princeton, NJ 08543 Lic. # 2156 |
05/30/2024 |
| BREYANZI lisocabtagene maraleucel |
To add a new indication for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy, according to the regulations for accelerated approval, 21 CFR 601.41. | 125714/225 | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company 303 Science Park Rd. San Diego, CA 92121 Lic. # 2156 |
05/15/2024 |
| ALTUVIIIO antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl |
To update the ALTUVIIIO U.S. Package Insert (USPI) to include completed pediatric study results (EFC16295). | 125771/136 | Bioverativ Therapeutics, Inc. 55 Corporate Drive Bridgewater, NJ 08807 Lic. # 2078 |
05/10/2024 |
| CARVYKTI ciltacabtagene autoleucel |
To extend the indication based on the results of the CARTITUDE-4 clinical trial (NCT04181827) for treatment in lenalidomide-refractory participants, following 1 to 3 prior lines of therapy for multiple myeloma. This supplemental application also provides for a modification to the approved Risk Evaluation and Mitigation Strategy (REMS). | 125746/74 | Janssen Biotech, Inc. Janssen Research & Development, LLC 920 US Highway 202 Raritan, NJ 08869 Lic. # 1864 |
04/05/2024 |
| ABECMA idecabtagene vicleucel |
To include an indication for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. | 125736/218 | Celgene Corporation, a Bristol-Myers Squibb Company 3401 Princeton Pike Lawrenceville, NJ 08648 Lic. # 2252 |
04/04/2024 |
| IXINITY Coagulation Factor IX (Recombinant) |
To fulfill the required pediatric assessment for coagulation factor IX (recombinant) per STN BL 125426/222, and to expand the label to include pediatric patients <12 years of age for the treatment of Hemophilia B based on the data derived from the PMR study. | 125426/223 | Medexus Pharma, Inc. 29 N Wacker Ave Chicago, IL 60606 Lic. # 2220 |
03/22/2024 |
| BREYANZI lisocabtagene maraleucel |
To support a new indication in relapsed/ refractory chronic lymphocytic leukemia or small lymphocytic lymphoma in patients who have received at least two prior lines of therapy including a Bruton’s tyrosine kinase (BTK) inhibitor and a B-cell lymphoma-2 (BCL-2) inhibitor, according to the regulations for accelerated approval, 21 CFR 601.41. | 125714/205 | Juno Therapeutics, Inc., a Bristol- Myers Squibb Company 1000 Dexter Ave. N., Suite 1200 Seattle, WA 98109 Lic. # 2156 |
03/14/2024 |
| FLUCELVAX Influenza Vaccine |
To include a trivalent influenza vaccine formulation FLUCELVAX for use in individuals 6 months of age and older. | 125408/575 | Seqirus Inc. 475 Green Oaks Parkway Holly Springs, NC 27540 Lic. # 2049 |
03/04/2024 |
| GAMMAGARD LIQUID Immune Globulin Infusion (Human) |
To improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). | 125105/2023 | Takeda Pharmaceuticals U.S.A., Inc. 650 E. Kendall Street Cambridge, MA 02142 Lic. # 1898 |
01/26/2024 |
| HYQVIA Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase |
For treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. | 125402/885 | Takeda Pharmaceuticals U.S.A., Inc. 650 E. Kendall Street Cambridge, MA 02142 Lic. # 1898 |
01/12/2024 |