Investigational nAMD drug: RTH258
Novartis (NVS) plans to submit to an FDA application seeking regulatory approval for an investigational drug, RTH258 (Brolucizumab). This drug had a neovascular age-related macular degeneration (or nAMD) indication in 2018.
RTH 258 belongs to the anti-vascular endothelial growth factor (or anti-VEGF) class of drugs, which are reimbursed under Medicare Part B. This investigational therapy is expected to be launched commercially in 2019.
The diagram above shows the severity of nAMD and the factors that can cause existing anti-VEGF therapies to undertreat patients. Because these therapies must be injected monthly or bimonthly, the high-frequency dosing regimens negatively affect overall patient compliance and adherence rates.
The frequent monitoring required to evaluate treatment response in these patients also stresses the clinic capacity, a factor that further aggravates under-utilization trend in nAMD indication. Underutilization of existing anti-VEGF therapies—as much as five injections in one year—resulted in a decline in these patients’ vision.
The total anti-VEGF sales in the nAMD, diabetic macular edema (or DME), and Retinal vein occlusion (or RVO) markets in the US were worth $4.8 billion at the end of 2016. The anti-VEGF market in the nAMD, DME, and RVO indications in markets outside the US was valued at ~$4.1 billion at the end of 2016.
Evaluate Pharma has projected that the anti-VEGF market in nAMD, DME, and RVO indications in the US could grow at a CAGR[1. compound average growth rate] of 3.6% and reach $5.9 billion at the end of 2022.
The ex-US market in these indications is expected to rise at CAGR of 0.8% and reach $4.3 billion at the end of 2022. So, the overall anti-VEGF market in the nAMD, RVO, and DME indications could rise at a CAGR of 2.4% by the end of 2022.
Novartis expects to leverage the growing demand in the nAMD indication as well as the need for newer therapies with lower dosage frequency with its investigational therapy, RTH258. The company plans to challenge the existing nAMD market leader, Regeneron (REGN), as well as other potential nAMD players such as Roche Holdings (RHHBY) and Allergan (AGN).
In the next article, we’ll discuss clinical trial data for RTH258.