Novartis Announces China Approval of Two New Indications for Lucentis® (Ranibizumab)

Today, Novartis announced that Lucentis® (ranibizumab injection) was approved by China’s National Medical Products Administration (NMPA) on August 17 for the treatment of diabetic retinopathy (DR) and retinopathy of prematurity (ROP). These mark two additional new indications approved for Lucentis in China, following its previous approvals for wet age-related macular degeneration (wAMD), diabetic macular edema (DME), retinal vein occlusion (RVO) with secondary macular edema, and choroidal neovascularization (CNV).

According to reports, there are 120 million patients with type 2 diabetes in China, and the prevalence of diabetic retinopathy among diabetic patients in the country is as high as 25%–38%, making it the leading cause of visual impairment and blindness in this population. Lucentis was approved in China in November 2018 for the treatment of diabetic macular edema (DME). Over the past three years, it has been widely utilized in clinical practice. The press release noted that with the approval of this new indication, Lucentis has become the only anti-vascular endothelial growth factor (anti-VEGF) drug in China currently approved for both diabetic macular edema and diabetic retinopathy. This development is expected to better support Chinese patients with diabetic eye diseases in achieving comprehensive management through the "integrated treatment of both conditions."

Retinopathy of prematurity (ROP) is a developmental vasoproliferative disorder caused by the incomplete development of retinal vasculature in premature infants. In China, where millions of premature infants are born annually, ROP is a leading cause of severe visual impairment and even blindness in children; however, no approved drug therapy was previously available. Lucentis (ranibizumab), an anti-vascular endothelial growth factor (anti-VEGF) agent, has been approved for the treatment of ROP. Compared with conventional laser therapy, it offers a safer and more effective treatment option for affected infants, bringing renewed therapeutic hope to their families.

Since its launch in China in 2011, Lucentis® has been approved for multiple key ophthalmic indications, including wet age-related macular degeneration, diabetic macular edema, retinal vein occlusion and secondary macular edema, and choroidal neovascularization, benefiting nearly one million Chinese patients with fundus diseases.

We congratulate on the approval of the new indication for this drug and look forward to it benefiting more patients.

References:

[1] Major News | Lucentis® Receives Approval for Two Indications!. Retrieved 2021-08-19, from https://mp.weixin.qq.com/s/KkKdD7cFeLtArhWhLmdSTw