| Janssen Biotech, Inc. |
57894046901 |
TALVEY™ (talquetamab) Strength: 3 mg Form: 1 single vial Package Size: 1 |
Brand |
FDA |
2023-08-10 |
777.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with relapsed/refractory multiple myeloma who have received four prior lines of therapy including a proteosome inhibitor, immunomodulatory agent, and CD-38 therapy. The pricing plan has WAC set for the 3 mg/1.5 mL vial at $777.00. The list price of TALVEY will also be discounted as required under the 340 B program, Federal Supply Schedule, and other government programs.
In July 2023, the European Commission (EC) granted conditional marketing authorisation (CMA) of TALVEY (Talquetamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. European approval allows Janssen to market TALVEY in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices |
None |
35730 |
1 |
1 |
None |
None |
None |
None |
There are 35,730 newly diagnosed patients with multiple myeloma each year. TALVEY is indicated for patients with relapsed refractory disease. Exact information for the TALVEY indicated population is not available in the public domain. |
None |
| Janssen Biotech, Inc. |
57894047001 |
TALVEY™ (talquetamab) Strength: 40 mg Form: 1 single vial Package Size: 1 |
Brand |
FDA |
2023-08-10 |
10360.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with relapsed/refractory multiple myeloma who have received four prior lines of therapy including a proteosome inhibitor, immunomodulatory agent, and CD-38 therapy. The pricing plan has WAC set for the 40 mg/1.0 mL vial at $10,360.00. The list price of TALVEY will also be discounted as required under the 340 B program, Federal Supply Schedule, and other government programs.
In July 2023, the European Commission (EC) granted conditional marketing authorisation (CMA) of TALVEY (Talquetamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. European approval allows Janssen to market TALVEY in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices |
None |
35730 |
1 |
1 |
None |
None |
None |
None |
There are 35,730 newly diagnosed patients with multiple myeloma each year. TALVEY is indicated for patients with relapsed refractory disease. Exact information for the TALVEY indicated population is not available in the public domain. |
None |
| Janssen Biotech, Inc. |
57894010060 |
AKEEGA™ (niraparib and abiraterone acetate)Strength: 100mg/500mg Form: Tablet Package Size: 60 |
Brand |
FDA |
2023-08-15 |
18750.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with BRCA+ mCRPC. The pricing plan has monthly WAC set for both AKEEGA NDCs to be $18,750. The list price of AKEEGA will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs.
In April 2023, the European Commission (EC) granted marketing authorisation for AKEEGA (niraparib and abiraterone acetate [AA]), in the form of a dual action tablet (DAT), given with prednisone for treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
European approval allows Janssen to market AKEEGA in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices |
None |
35000 |
1 |
1 |
None |
None |
None |
None |
Estimate of 35,000 patients based on who will be treated for mCRPC specifically for Line 1. Exact usage of AKEEGA based on indicated population is not available in the public domain |
None |
| Janssen Biotech, Inc. |
57894005060 |
AKEEGA™ (niraparib and abiraterone acetate)Strength: 50mg/500mg Form: Tablet Package Size: 60 |
Brand |
FDA |
2023-08-15 |
18750.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we plan to market in the US and promote to appropriate healthcare professionals who treat individuals diagnosed with BRCA+ mCRPC. The pricing plan has monthly WAC set for both AKEEGA NDCs to be $18,750. The list price of AKEEGA will also be discounted as required under the 340B program, Federal Supply Schedule, and other government programs.
In April 2023, the European Commission (EC) granted marketing authorisation for AKEEGA (niraparib and abiraterone acetate [AA]), in the form of a dual action tablet (DAT), given with prednisone for treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
European approval allows Janssen to market AKEEGA in all member states of the European Union and the European Economic Area. International pricing plans are based on ensuring compliance with local laws and processes. Member states pricing and reimbursement negotiations are ongoing and are based upon local funding choices |
None |
35000 |
1 |
1 |
None |
None |
None |
None |
Estimate of 35,000 patients based on who will be treated for mCRPC specifically for Line 1. Exact usage of AKEEGA based on indicated population is not available in the public domain |
None |