Tags : EYLEA

Top 20

Top 20 Prescription Drugs Based on 2019 Revenue

The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they […]Read More

Biosimilars

Samsung Bioepis Reports the Initiation of P-III Study for SB15

Shots: The P-III study will compare the efficacy, safety, PK, and immunogenicity between SB15 and Eylea in 446 patients with neovascular age-related macular degeneration The company has two ophthalmology biosimilar candidates in clinical development, SB11 (ranibizumab) and SB15 (aflibercept). On May 18, 2020, Samsung Bioepis reports 24-week interim results from a P-III study of SB11 […]Read More

Biotech

Bayer Launches Eylea (aflibercept) Pre-Filled Syringe in Europe

Shots: The EMA has approved Bayer’s Eylea® (aflibercept) injection pre-filled syringe with the EC’s decision applies to all 27 EU member states as well as the UK, Iceland, Norway and Liechtenstein The P-IV ALTAIR study assessing Eylea (aflibercept) with T&E dosing regimens in patients with wet AMD, demonstrated a reduction in injection burden, i.e. up […]Read More

Regulatory

Bayer Reports Submission of MAA to the EMA for Pre-Filled

Shots: Bayer has applied for the approval to the EMA for its pre-filled syringe to administer Eylea for five retinal indications including neovascular wet AMD, macular edema following RVO, DME, myopic CNV Following the state-of-the-art pre-filled syringe of Eylea is approved, it would be the new option for treatment requiring fewer steps to prepare IVT […]Read More

Regulatory

Regeneron’s Eylea (aflibercept) Receives the US FDA’s Approval as a

Shots: The US FDA has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the Eylea (2mg, single dose) sterilized prefilled syringe with its expected availability to the physicians and patients in H2’19 The sterilized prefilled syringe offers the same medication as the currently available Eylea providing ease of administration and is available […]Read More

Regulatory

Regeneron’s Eylea (aflibercept) Injection Receives FDA’s Approval for Diabetic Retinopathy

Shots: The approval is based on P-III PANORAMA study results assessing Eylea (q8w, q16w) vs sham in 402 patients with non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME) The P-III PANORAMA study results: improvement on DRSS score by ≥2‑step (80%,65% vs 15%); @q16w & @q8w, reduction in risk (85% & 88%); @q8w, improvement in […]Read More

Pharma

Regeneron Announces FDA Review Acceptance of EYLEA’s sBLA for the

Shots: The sBLA involves results of P-III PANORAMA trial assessing EYLEA treatment from moderate severe-to-severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME) The announced PDUFA date for EYLEA by US FDA is 13 May, 2019. PANORAMA six months’ results has been announced in March 2018 with expected one year results in H2’18 EYLEA […]Read More