TARRYTOWN, NY, USA I August 13, 2018 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that due to ongoing labeling discussions the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on the second year data from the VIEW studies during which patients were treated with a modified 12 week dosing schedule (doses given at least every 12 weeks and additional doses as needed). Regeneron expects to complete these discussions and receive a final FDA action within approximately two months.
About EYLEA® (aflibercept) Injection
EYLEA® (aflibercept) Injection is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. In the U.S., EYLEA is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes seven pivotal Phase 3 trials.
EYLEA is currently approved in wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.
Regeneron and Bayer AG collaborate on the global development and commercialization of EYLEA. Regeneron maintains exclusive rights to EYLEA in the U.S. Bayer has licensed the exclusive marketing rights outside the U.S., where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage of net sales.
INDICATIONS
EYLEA® (aflibercept) Injection is a prescription medicine approved for the treatment of patients with:
Wet Age-related Macular Degeneration (AMD): The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 3 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 3 months (12 weeks).
Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose for EYLEA is 2 mg administered by injection in the eye monthly (every 4 weeks).
Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in patients with DME: The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 5 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 5 months (20 weeks).
Please visit www.EYLEA.us to see the full Prescribing Information for EYLEA.
The information contained herein is provided for general educational purposes. If you have any questions, talk to your doctor.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
SOURCE: Regeneron Pharmaceuticals
Post Views: 26
TARRYTOWN, NY, USA I August 13, 2018 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that due to ongoing labeling discussions the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on the second year data from the VIEW studies during which patients were treated with a modified 12 week dosing schedule (doses given at least every 12 weeks and additional doses as needed). Regeneron expects to complete these discussions and receive a final FDA action within approximately two months.
About EYLEA® (aflibercept) Injection
EYLEA® (aflibercept) Injection is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. In the U.S., EYLEA is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes seven pivotal Phase 3 trials.
EYLEA is currently approved in wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.
Regeneron and Bayer AG collaborate on the global development and commercialization of EYLEA. Regeneron maintains exclusive rights to EYLEA in the U.S. Bayer has licensed the exclusive marketing rights outside the U.S., where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage of net sales.
INDICATIONS
EYLEA® (aflibercept) Injection is a prescription medicine approved for the treatment of patients with:
Wet Age-related Macular Degeneration (AMD): The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 3 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 3 months (12 weeks).
Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose for EYLEA is 2 mg administered by injection in the eye monthly (every 4 weeks).
Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in patients with DME: The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 5 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 5 months (20 weeks).
Please visit www.EYLEA.us to see the full Prescribing Information for EYLEA.
The information contained herein is provided for general educational purposes. If you have any questions, talk to your doctor.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
SOURCE: Regeneron Pharmaceuticals
Post Views: 26
