October 2020 decisions expected from the FDA

At Prime Therapeutics (Prime), we’ve positioned ourselves to best prepare our clients to manage the new drugs that come on the market. Our clinical and trade relations teams keep a keen eye on drugs likely to be approved by the U.S. Food and Drug Administration (FDA).

10/24/2020: Rolontis™ (eflapegrastim)

The FDA is reviewing Spectrum Pharmaceuticals and Hanmi Pharmaceutical’s Rolontis as a long-acting granulocyte colony-stimulating factor (GM-CSF). Rolontis uses Hanmi’s lapscovery technology for treatment of chemotherapy-induced neutropenia. Rolontis is a health care administered prefilled subcutaneous injection. Rolontis’ application is based on the Phase 3 ADVANCE trial that achieved an absolute risk reduction in severe neutropenia of 8.5 percentage points compared with Amgen Neulasta® (84.2% versus 75.7%).1 ADVANCE demonstrated Rolontis was non-inferior in reducing the duration of severe chemotherapy-induced neutropenia in comparison with Neulasta. Phase 3 clinical trial RECOVER also demonstrated Rolontis to be non-inferior to Neulasta in reduction of duration of severe neutropenia in patients with early-stage breast cancer receiving chemotherapy.

10/25/2020: REGN-EB3 (REGN3470-3471-3479)

Regeneron’s REGN-EB3 is being reviewed by the FDA for treatment of Ebola. REGN-EB3 is a triple combination medication of atoltivimab, odesivimab, and maftivimab. In 2019, the controlled trial PALM was stopped early when preliminary results showed that REGN-EB3 crossed the pre-specified superiority threshold for preventing death compared to the control arm, ZMapp. REGN-EB3 demonstrated superior efficacy compared to ZMapp across multiple measures, including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream.2 The therapies saved roughly 90 percent of the patients who were newly infected, a turning point in the decades-long fight against the virus. There are currently no similar products approved for Ebola.

10/30/2020: Eysuvis™ (loteprednol etabonate 0.25%(KPI-121))

The FDA is reviewing Kala Pharmaceuticals’ Eysuvis as temporary relief for the signs and symptoms of dry eye disease. Kala Pharmaceuticals utilizes a two-week course of therapy and, if approved, would be the first short-term treatment for dry eye flares. Eysuvis’ application is based on the Phase 3 STRIDE 3 trial, that demonstrated statistically significant improvement in ocular discomfort severity. For secondary endpoints, patients treated with Eysuvis experienced a statistically significant improvement in conjunctival hyperemia, with significant results seen for a total corneal staining at day 15.3 In August 2019, the FDA issued a complete response letter (CRL) that required loteprednol etabonate to conduct a new efficacy trial. Similar products include Allergan’s Restasis® (cyclosporine ophthalmic emulsion), Aton Pharma’s Lacrisert® (hydroxypropyl cellulose ophthalmic insert), and Shire’s Xiidra® (lifitegrast ophthalmic solution).

Quarter 4 2020: FYB201 (Lucentis® (ranibizumab) biosimilar)

The FDA is reviewing Coherus Biosciences’ FYB201 as a Lucentis® (ranibizumab) biosimilar for the treatment of ‘wet’ form of age-related macular degeneration (AMD), other sight problems associated with choroidal neovascularization, macular edema caused by diabetes and macular oedema caused by occlusion of the veins behind the retina. FYB201’s application is based on a Phase 3 clinical trial that demonstrated comparable safety, efficacy and immunogenicity of FYB201 to Lucentis.4 FYB201 is the first Lucentis biosimilar applicant and will be scheduled to launch upon approval.

While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion. Those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner.

1. https://www.oncnursingnews.com/web-exclusives/fda-accepts-bla-for-eflapegrastim-for-chemo-induced-neutropenia

2. https://newsroom.regeneron.com/news-releases/news-release-details/palm-ebola-clinical-trial-stopped-early-regenerons-regn-eb3

3. https://www.healio.com/news/ophthalmology/20200310/kalas-dry-eye-treatment-meets-primary-secondary-endpoints-in-phase-3-trial#:~:text=KPI%2D121%200.25%25%20(loteprednol,mucus%2Dpenetrating%20drug%20delivery%20technology.

4. https://www.bioeq.com/development-programs/fyb201/#:~:text=bioeq’s%20lead%20product%2C%20FYB201%2C%20is,bioeq’s%20license%20partner%20Formycon%20AG.&text=The%20introduction%20of%20the%20FYB201,and%20in%20Europe%20in%202022.