Biohaven Ltd. has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its novel anti-myostatin adnectin, taldefgrobep alfa, for treating spinal muscular atrophy (SMA). This designation allows for quicker communication with the FDA and expedited review of the drug, which addresses an unmet medical need for a serious condition. Biohaven had previously received orphan drug designation from the FDA for taldefgrobep in the treatment of SMA.

Publish Date: 21-02-2023 Source: Biohaven Ltd.

Geographic atrophy (GA) is defined as the late stage of the dry form of age-related macular degeneration (AMD). Some patients with age-related macular degeneration (AMD) may develop geographic atrophy (GA), which refers to regions of the retina where cells waste away and die (atrophy). The edge of GA was recognized as the termination of continuous RPE. Internal to the edge, there was an absence of RPE cells over wide areas, although a few RPE cells were scattered over the area of GA. The first visible alterations of AMD are drusen and retinal pigment epithelial (RPE) irregularities. This early stage of age-related maculopathy (ARM) may progress to either geographic atrophy (GA) or exudative AMD. Approximately 11% of patients with atrophic AMD eventually progress to the exudative form at four years of evolution. In some eyes with choroidal neovascularisation (CNV) also leads to GA.

• In the USA, the prevalence of GA is 3.5% in subjects older than 65 years, accounting for approximately half the prevalence of exudative AMD.

However, the current Spinal Muscular Atrophy (SMA) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (OAV101, Apitegromab, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Spinal Muscular Atrophy treatment. The key companies in the advanced development stage are Novartis, Scholar Rock, Inc., etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Spinal Muscular Atrophy (SMA) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

Thelansis specializes in pharmaceutical market outlook and market forecast reports. We published reports across the therapeutic area, including rare / ultra-rare and mainstream indications. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

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