Memorandum

FDA approves Genentech/Roche’s Lucentis (ranibizumab) for diabetic retinopathy without DME – April 19, 2017

Executive Highlights

  • Genentech announced the FDA approval of Lucentis (ranibizumab) as the only drug indicated for the treatment of all forms of diabetic retinopathy.
  • Lucentis was approved in February 2015 for the treatment of diabetic retinopathy in people with DME, but approval expands the indication to people without DME as well.

Genentech, a subsidiary of Roche, announced the FDA approval of Lucentis (ranibizumab) for diabetic retinopathy without diabetic macular edema (DME) earlier this week. This decision arrives on a significantly accelerated timeline due to the FDA granting priority review for this area of high unmet need. Roche filed Lucentis with the FDA for this indication in October 2016, which would have suggested a 2H17 decision assuming a standard 10-12 month review process. We’re very pleased by the expedited approval and the FDA’s recognition of the immense need in this area. The decision establishes Lucentis, a 0.3 mg monthly injection of anti-vascular endothelial growth factor (anti-VEGF) agent, as the first and only FDA-approved medication to treat all forms of diabetic retinopathy, both with and without diabetic macular edema (DME). Lucentis was previously approved for the treatment of diabetic retinopathy in people with DME in February 2015 based on data from the RIDE and RISE phase 3 clinical trials and is marketed by Roche in the US and Novartis ex-US. This approval expands Lucentis’ indication to the treatment of diabetic retinopathy in people without DME on the basis of the NIH-funded Protocol S study, in which 38% of participants without DME experienced a two-step or better improvement in diabetic retinopathy with Lucentis and 28% experienced a three-step or better improvement (n=148) according to the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS). Participants with DME experienced at least a two-step or three-step improvement in diabetic retinopathy in 59% and 32% of cases, respectively (n=41). The approval of Lucentis is fantastic news for patients given the wide scope of diabetic retinopathy (affecting nearly 8 million people in the US) and the fact that retinopathy/blindness is one of the most frequently cited fears among patients with diabetes.

  • We’re optimistic that this expanded indication may help boost revenue for the drug – Lucentis has experienced sluggish sales in recent quarters both in the US and abroad. In 4Q16, for instance, Roche’s US revenues for Lucentis fell 14% YOY in constant currencies to $329 million and Novartis’ ex-US revenues fell 9% in constant currencies to $452 million. This competition comes primarily from Bayer/Regeneron’s Eylea (intravitreal afibercept), which holds 40% of all major markets as per Bayer’s 2Q16 update, and from Genentech’s Avastin (bevacizumab), which has been used off-label in diabetic macular edema and diabetic retinopathy due to its significantly lower cost. We have no information on how this approval may impact the steep pricing of Lucentis, but we hope payers will be compelled to place Lucentis favorably on their formularies given that it is the only available treatment option indicated for all forms of diabetic retinopathy in the US.
  • In 3Q16 the FDA approved a 0.5 mg prefilled syringe to administer Lucentis. This is the first FDA-approved prefilled syringe for an anti-vascular endothelial growth factor (anti-VEGF) agent, and the company announcement underscored that this ready-to-use option will offer added convenience to patients using Lucentis to treat macular degeneration or macular edema. It’s too soon to say how the prefilled syringe and convenience factor will impact Lucentis sales vs. Eyelea and Avastin, but we’ll be watching closely for this in future quarters.
  • The phase 2 LADDER study is ongoing to assess delivery of Lucentis via implant versus the typical intravitreal delivery method. The trial (n=220) is scheduled to complete in May 2018, with a goal to expand Lucentis’ indication to a port delivery device – a much more patient-friendly option.

 

-- by Abigail Dove, Helen Gao, and Kelly Close