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Roche's (RHHBY) SMA Treatment Evrysdi Secures EC Approval
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Roche (RHHBY - Free Report) announced that the European Commission (EC) has approved its spinal muscular atrophy drug (SMA) Evrysdi.
The drug is approved for the treatment of 5q SMA in patients who are two months older and above with a clinical diagnosis of SMA type 1, type 2 or type 3 or with one to four SMN2 copies.
SMA is a severe, progressive neuromuscular disease that causes muscle weakness and progressive loss of movement affecting one in 10,000 babies and is the leading genetic cause of infant mortality.
The regulatory nod was based on data from two clinical studies, namely FIREFISH in symptomatic type 1 infants, aged from two months to seven months and SUNFISH in symptomatic type 2 and 3 children and adults, aged between two years and 25 years. Evrysdi demonstrated a favorable efficacy and safety profile in both studies.
An approval was in the cards as the Committee for Medicinal Products for Human Use (CHMP) gave a positive recommendation for the same in February 2021.
The review was completed under the accelerated assessment pathway for medicines.
We note that Evrysdi was granted a PRIME designation by the European Medicines Agency (EMA) in 2018 and an Orphan Drug Designation in 2019.
Evrysdi can be administered daily at home in liquid form through mouth or by feeding tube.
Roche is developing Evrysdi in collaboration with the SMA Foundation and PTC Therapeutics (PTCT - Free Report) . It is already approved in the United States.
The approval will strengthen Roche’s neuroscience portfolio. While pricing will play a key role in the drug’s uptake, competition is stiff in the SMA market from the likes of Biogen’s (BIIB - Free Report) Spinraza and Novartis’ (NVS - Free Report) gene therapy Zolgensma.
Shares of Roche have declined 8.2% so far this year against the industry’s increase of 0.7%.
Roche is a leader in the oncology space. The company is looking to diversify and strengthen its portfolio beyond oncology and explore neuroscience among others. Approval of new drugs in other therapeutic areas will enable the company to establish a foothold in these spaces.
Roche currently carries a Zacks Rank #5 (Strong Sell).
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Roche's (RHHBY) SMA Treatment Evrysdi Secures EC Approval
Roche (RHHBY - Free Report) announced that the European Commission (EC) has approved its spinal muscular atrophy drug (SMA) Evrysdi.
The drug is approved for the treatment of 5q SMA in patients who are two months older and above with a clinical diagnosis of SMA type 1, type 2 or type 3 or with one to four SMN2 copies.
SMA is a severe, progressive neuromuscular disease that causes muscle weakness and progressive loss of movement affecting one in 10,000 babies and is the leading genetic cause of infant mortality.
The regulatory nod was based on data from two clinical studies, namely FIREFISH in symptomatic type 1 infants, aged from two months to seven months and SUNFISH in symptomatic type 2 and 3 children and adults, aged between two years and 25 years. Evrysdi demonstrated a favorable efficacy and safety profile in both studies.
An approval was in the cards as the Committee for Medicinal Products for Human Use (CHMP) gave a positive recommendation for the same in February 2021.
The review was completed under the accelerated assessment pathway for medicines.
We note that Evrysdi was granted a PRIME designation by the European Medicines Agency (EMA) in 2018 and an Orphan Drug Designation in 2019.
Evrysdi can be administered daily at home in liquid form through mouth or by feeding tube.
Roche is developing Evrysdi in collaboration with the SMA Foundation and PTC Therapeutics (PTCT - Free Report) . It is already approved in the United States.
The approval will strengthen Roche’s neuroscience portfolio. While pricing will play a key role in the drug’s uptake, competition is stiff in the SMA market from the likes of Biogen’s (BIIB - Free Report) Spinraza and Novartis’ (NVS - Free Report) gene therapy Zolgensma.
Shares of Roche have declined 8.2% so far this year against the industry’s increase of 0.7%.
Roche is a leader in the oncology space. The company is looking to diversify and strengthen its portfolio beyond oncology and explore neuroscience among others. Approval of new drugs in other therapeutic areas will enable the company to establish a foothold in these spaces.
Roche currently carries a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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