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FDA Breakthrough Therapy: Approval of Genentech’s Lucentis For Diabetic Retinopathy

February 9, 2015

Genentech announces February 6th that the FDA approves Lucentis (Ranibizumab), once-monthly injection, for the treatment of Diabetic Retinopathy (DR) in people with Diabetic Macular Edema (DME). Lucentis is granted the Breakthrough Therapy Designation (BTD) and Priority Review for this indication based on results from both the RISE and RIDE Phase III clinical trials.

This is the 4th approved eye disease indication for Lucentis since 2006:

•   DR with DME

•   Diabetic Macular Edema (DME)

•   Neovascular (wet) Age-Related Macular Degeneration (AMD)

•   Macular edema following Retinal Vein Occlusion (RVO).

Diabetic retinopathy is a complication of diabetes that results in damaging the eye’s retina, that can lead to poor vision, vision loss, and other vision problems. This is the 1st FDA approved treatment for DR with DME.

In September 2014, Regeneron Pharmaceuticals receives the FDA BTD for Eylea (Afibercept) injection for DR with DME. Eylea is currently approved in the U.S., European Union (EU), and other countries for the treatment of wet Age-Related Macular Degeneration (AMD), macular edema following Central Retinal Vein Occulsion (CRVO), and DME. In the U.S. and the EU, regulatory submissions have been made for macular edema following Branch Retinal Vein Occulsion (BRVO). In December 2014, Regeneron Pharmaceuticals announces that the FDA accepts for Priority Review the sBLA for Eylea, for DR in patients with DME, with a target action date of March 30, 2015.

FDA CBER BTDs Receiving Approval (as of 01/23/15)

The FDA CBER Breakthrough Therapy Designations receiving approval (as of 01/23/15), 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 02/06/15)

The FDA CDER Breakthrough Therapy Designations receiving approval (as of 02/06/15), 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)

* 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



FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “Flickr – Nicholas T – Bows” by Nicholas A. Tonelli from Pennsylvania, USA (Bows) [CC-BY-2.0] | Wikimedia Commons.

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  1. Good article and helpful information. Thank you for sharing with us.

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