Ahead of Biosimilar Competition, Ranibizumab Gets a Positive CHMP Opinion for New Indication

Novartis, developer of the brand-name Lucentis, announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted the drug a positive opinion for the treatment of retinopathy of prematurity in infants.
July 28, 2019
Biosimilars of ranibizumab (Lucentis) are on the horizon, with developers including Xbrane, Coherus BioSciences, and Samsung Bioepis all advancing proposed biosimilars referencing the anti–vascular endothelial growth factor (anti-VEGF) therapy. However, ahead of facing competition, the eye drug could gain a new European indication.

Novartis, developer of the brand-name Lucentis, announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted the drug a positive opinion for the treatment of retinopathy of prematurity (ROP) in infants. ROP is a rare eye disease that is the leading cause of childhood blindness. ROP affects premature infants and is caused by the abnormal development of retinal blood vessels spurred by high levels of VEGF.

If ranibizumab is approved in this indication, it will be the first time that a drug has been approved for this patient population.

The CHMP opinion relied on data from the RAINBOW clinical study, which was conducted among 224 participants at 87 sites worldwide. Patients with ROP were randomized to receive 1 of 3 therapies: 0.2 mg of ranibizumab injected on day 1 and up to 2 retreatments for each eye, 0.1 mg of ranibizumab on day 1 and up to 2 retreatments per eye, or laser therapy.

The primary outcome measure was the percentage of patients with an absence of active ROP and an absence of unfavorable structural outcomes in both eyes at week 24. In total, 80% of patients who received 0.2 mg of ranibizumab and 75% of those who received 0.1 mg of ranibizumab achieved this outcome versus 66.2% of patients who received laser therapy. Adverse events were reported in 35.62%, 31.58%, and 34.78% of patients in the 3 groups, respectively.
 
“Given this vulnerable patient population, and the limitations of current treatments, randomized controlled clinical studies are important to ensure safe and effective use of pharmacological therapies in pediatric patient populations. If approved, ranibizumab will be a valuable alternative treatment option to laser therapy,” commented Andreas Stahl, MD, director of the department of ophthalmology, University Medical Center Greifswald, in a statement announcing the CHMP opinion.

Novartis indicated that it expects to receive the European Commission’s decision on the drug within the next 3 months.

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