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Roche's (RHHBY) BLA for PDS With Ranibizumab Accepted by FDA
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Roche (RHHBY - Free Report) announced that the FDA has accepted its Biologics License Application (BLA) for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD).
The agency granted Priority Review to the application and will make a decision by Oct 23, 2021.
A tentative approval will make PDS a first-of-its-kind therapeutic approach, offering nAMD patients an alternative to frequent eye injections of anti-vascular endothelial growth factor (VEGF), the current standard of care.
Ranibizumab intravitreal injection is marketed under the brand name Lucentis (ranibizumab injection) to treat nAMD and other retinal diseases.
PDS is a permanent refillable eye implant. It is designed to continuously deliver a customized formulation of ranibizumab over a few months, which in turn will potentially reduce the treatment burden associated with frequent eye injections. The BLA submission was based on positive results from the phase III Archway study primary analysis. The results showed that more than 98% of the nAMD patients being treated with PDS were able to go six months without needing additional treatment prior to the refill exchange.
Additionally, these patients achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections. PDS was generally well-tolerated, with a favorable benefit-risk profile.
The Marketing Authorization Application for the same has also been validated by the European Medicines Agency and is currently under review.
We note that Roche has a broad late-stage development program underway for PDS, including the Portal, Pagoda and Pavilion studies. Portal is an extension study evaluating the long-term safety and efficacy of PDS in nAMD. Pagoda is evaluating PDS for the treatment of diabetic macular edema (DME), while Pavilion is a study of PDS in diabetic retinopathy without DME. Enrollment is ongoing in both Pagoda and Pavilion studies.
Roche’s stock has gained 7% in the year so far compared with the industry’s growth of 6.8%.
Image Source: Zacks Investment Research
Its ophthalmology pipeline includes two potential first-of-a-kind treatments — PDS with ranibizumab and faricimab — which are being evaluated in a number of retinal conditions, including nAMD, DME, and diabetic retinopathy.
The early-stage pipeline includes gene therapies and treatments for geographic atrophy and other vision-threatening diseases.
Other drugs approved for nAMD include Regeneron’s (REGN - Free Report) Eylea and Novartis’ (NVS - Free Report) Beovu.
Repligen’s earnings estimates for 2021 have increased to $2.26 from $1.91 in the past 60 days. The stock price has increased 1.7% in the year so far.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
Image: Bigstock
Roche's (RHHBY) BLA for PDS With Ranibizumab Accepted by FDA
Roche (RHHBY - Free Report) announced that the FDA has accepted its Biologics License Application (BLA) for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD).
The agency granted Priority Review to the application and will make a decision by Oct 23, 2021.
A tentative approval will make PDS a first-of-its-kind therapeutic approach, offering nAMD patients an alternative to frequent eye injections of anti-vascular endothelial growth factor (VEGF), the current standard of care.
Ranibizumab intravitreal injection is marketed under the brand name Lucentis (ranibizumab injection) to treat nAMD and other retinal diseases.
PDS is a permanent refillable eye implant. It is designed to continuously deliver a customized formulation of ranibizumab over a few months, which in turn will potentially reduce the treatment burden associated with frequent eye injections.
The BLA submission was based on positive results from the phase III Archway study primary analysis. The results showed that more than 98% of the nAMD patients being treated with PDS were able to go six months without needing additional treatment prior to the refill exchange.
Additionally, these patients achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections. PDS was generally well-tolerated, with a favorable benefit-risk profile.
The Marketing Authorization Application for the same has also been validated by the European Medicines Agency and is currently under review.
We note that Roche has a broad late-stage development program underway for PDS, including the Portal, Pagoda and Pavilion studies. Portal is an extension study evaluating the long-term safety and efficacy of PDS in nAMD. Pagoda is evaluating PDS for the treatment of diabetic macular edema (DME), while Pavilion is a study of PDS in diabetic retinopathy without DME. Enrollment is ongoing in both Pagoda and Pavilion studies.
Roche’s stock has gained 7% in the year so far compared with the industry’s growth of 6.8%.
Its ophthalmology pipeline includes two potential first-of-a-kind treatments — PDS with ranibizumab and faricimab — which are being evaluated in a number of retinal conditions, including nAMD, DME, and diabetic retinopathy.
The early-stage pipeline includes gene therapies and treatments for geographic atrophy and other vision-threatening diseases.
Other drugs approved for nAMD include Regeneron’s (REGN - Free Report) Eylea and Novartis’ (NVS - Free Report) Beovu.
Roche currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Repligen Corporation (RGEN - Free Report) , which presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates for 2021 have increased to $2.26 from $1.91 in the past 60 days. The stock price has increased 1.7% in the year so far.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
Click here for the 4 trades >>