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FDA Breakthrough Therapy Designation Approval Chart

December 9, 2013
Idea

 

 

 

 

The Total FDA BTD Approval Chart is divided into 2 charts:

•   FDA CBER BTDs Receiving Approval

•   FDA CDER BTDs Receiving Approval.

FDA CBER BTDs Receiving Approval (as of 01/31/15)

The FDA CBER Breakthrough Therapy Designations receiving approval (as of 01/31/15), in ascending chronological “FDA Approval Date” order, are as follows:

Drug Name FDA Approval Date Sponsor Company Indication
Trumenba (Meningococcal Group B Vaccine) ***** 10.29.14 Pfizer Meningococcal B Disease
Bexsero (Meningococcal Group B Vaccine) ***** 01.23.15 Novartis Meningococcal B Disease

***** Accelerated Approval

FDA CDER BTDs Receiving Approval (as of 03/25/15)

The FDA CDER Breakthrough Therapy Designations receiving approval (as of 03/25/15), in ascending chronological “FDA Approval Date” order, are as follows:

Drug Name FDA Approval Date Sponsor Company Indication
Gazyva   (Obinutuzumab) 11.01.13 Genentech Chronic Lymphocytic Leukemia (CLL)
Imbruvica   (Ibrutinib) 11.13.13 Pharmacyclics Mantle Cell Lymphoma (MCL)
Sovaldi   (Sofosbuvir) 12.06.13 Gilead   Sciences Hepatitis C
Kalydeco (Ivacaftor)** 02.21.14 Vertex Pharmaceuticals 8 additional mutations in CFTR gene for Cystic Fibrosis (CF)
Arzerra (Ofatumumab) *** 04.17.14 GlaxoSmithKline In combination with Chlorambucil for previously untreated Patients with CLL for whom fludarabine-based therapy is considered inappropriate
Zykadia (Ceritinib) 04.29.14 Novartis Metastatic ALK+ NSCLC
Zydelig (Idelalisib) 07.23.14 Gilead Sciences Chronic Lymphocytic Leukemia (CLL)
Imbruvica (Ibrutinib)* 07.28.14 Pharmacyclics Chronic Lymphocytic Leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion)
Promacta (Eltrombopag)** 08.26.14 GlaxoSmithKline Severe Aplastic Anemia (SAA) with insufficient response to Immunosupporessive Therapy (IST)
Keytruda (Pembrolizumab) **** 09.04.14 Merck Unresectable/ Metastatic Melanoma, disease progression, & have BRAF V600 mutation, following treatment with Yervoy & a BRAF inhibitor
Harvoni (Ledipasvir /Sofosbuvir) 10.10.14 Gilead Sciences Genotype 1 Chronic HCV
Esbriet (Pirfenidone) 10.15.14 InterMune Idiopathic Pulmonary Fibrosis
Ofev (Nintedanib) 10.15.14 Boehringer Ingelheim Pharmaceuticals Idiopathic Pulmonary Fibrosis
Blincyto (Blinatumomab) 12.03.14 Amgen Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL)
Viekira Pak (Ombitasvir, Paritaprevir, Ritonavir) 12.19.14 AbbVie Chronic hepatitis C virus (HCV) genotype 1
Opdivo (Nivolumab) 12.22.14 Bristol-Myers Squibb Unresectable/ Metastatic Melanoma
Kalydeco (Ivacaftor) ** 12.29.14 Vertex Pharmaceuticals Cystic Fibrosis Ages 6 & older who have the R117H Mutation
Imbruvica (Ibrutinib) * 01.29.15 Pharmacyclics Waldenstrom’s Macroglobulinemia (WM)
Ibrance (Palbociclib) ***** 02.03.15 Pfizer Postmenopausal women with ER+/HER2- advanced breast cancer, as initial endocrine-based therapy for metastatic disease
Lucentis (Ranibizumab Injection) * 02.06.15 Genentech Diabetic Retinopathy (DR) with  Diabetic Macular Edema (DME)
Kalydeco (Ivacaftor) * 03.18.15 Vertex Pharmaceuticals Cystic Fibrosis Ages 2 to 5 who have 1 of 10 mutations in the CFTR gene
Eylea (Aflibercept Injection) * 03.25.15 Regeneron Pharmaceuticals Diabetic Retinopathy (DR) with  Diabetic Macular Edema (DME)

* Expanded the approved use

**   Approval for a Supplemental New Drug Application (sNDA)

*** Approval for a Supplemental Biologic License Application (sBLA)

**** Pembrolizumab formerly known as Lambrolizumab

***** Accelerated Approval

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note : “Idea” PNG by Producer at ar.wikipedia (Transferred from ar.wikipedia) [Public domain] | Wikimedia Commons.

Copyright © 2012-2015, Orphan Druganaut Blog. All rights reserved.

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