February is set to be a pivotal month for drug approvals, with the FDA poised to deliver three critical decisions. One of these could be a landmark first approval for a rare, neurodegenerative disease, while another could revolutionize the treatment of heart failure.
Moment of Truth for Cytokinetics’ Heart Failure Drug
On February 28th, the FDA will make a crucial decision that could revolutionize the treatment of heart failure with reduced ejection fraction. Cytokinetics’ novel, selective cardiac myosin activator, omecamtiv mecarbil (OM), is on the brink of FDA approval and could provide much-needed relief to those suffering from this condition. This decision could be a game changer for the millions of people worldwide affected by heart failure.
In February 2022, the regulatory agency accepted the New Drug Application for OM, setting a target action date of Nov. 30, 2022. However, in May, the company made a thrilling announcement – the FDA planned to hold an advisory committee meeting for the application, providing an exciting development in the drug’s journey to the market.
The FDA’s request for additional pharmacokinetic information for OM caused a major amendment to the NDA, resulting in a delay of the target action date to Feb. 28, 2023 – a full month later than expected.
In December, a panel of external experts on the FDA’s Cardiovascular and Renal Drugs Advisory Committee weighed in on the approval of OM drug, casting an unexpected 8-3 vote against. Despite mixed efficacy results and safety concerns, the panel voted against the drug, leaving many to question the results.
Will Reata Score First Friedreich’s Ataxia Nod?
Reata Pharmaceuticals is on the cusp of a major breakthrough in treating Friedreich’s ataxia, a rare neurological condition. On February 28, the company is expecting a decision on its drug, omaveloxolone, which could potentially bring relief to many suffering from the disorder. Omaveloxolone works by activating Nrf2, a transcription factor that helps reduce inflammation, restore mitochondrial function, and reduce oxidative stress and pro-inflammatory signaling.
In March 2022, Reata Pharmaceuticals completed its rolling NDA for omaveloxolone, but their progress was met with a setback in August when the FDA pushed back their target action date by three months due to the submission of additional confirmatory data being considered as a major amendment to the application.
Regeneron Seeks New Eylea Dosing Regimen
On February 28th, Regeneron is expecting an exciting decision from the FDA about a new dosing regimen for their popular eye drug Eylea (aflibercept). This could be a major breakthrough in the world of eye care, and the public is eager to see what the FDA’s verdict will be.
Regeneron has proposed a revolutionary new approach to treating diabetic retinopathy: administering 2-mg Eylea injections every 16 weeks after an initial series of monthly doses. This proposal was included in a supplemental Biologics License Application filed in June 2022, offering hope to those who suffer from this debilitating condition.
The PANORAMA study, a Phase III clinical trial, demonstrated that weekly dosing of a specific treatment could substantially improve Diabetic Retinopathy Severity Scale scores – and this finding was the basis of the sBLA. By receiving the treatment every 16 weeks, patients experienced at least two steps of improvement in their scores compared to those who received sham injections.
Eylea, the first pharmacologic therapy approved by the FDA for retinopathy of prematurity in preterm infants, is a game-changer in the world of eye care. The revolutionary treatment is also approved for diabetic retinopathy at 4- and 8-week doses, as well as wet age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema. With Eylea, eye care professionals have a powerful new tool to help restore vision and improve patients’ lives.
FDA Convenes AdComm for Pfizer and GSK’s RSV Shots
The FDA has scheduled an exciting double-header of advisory committee meetings to discuss the potential of two promising respiratory syncytial virus (RSV) vaccine candidates. On February 28th, experts will review Pfizer’s vaccine, followed by GSK’s on March 1st. It’s a thrilling chance to evaluate the efficacy and safety of these two vaccines in the hope of finding a groundbreaking solution to RSV.
GSK has taken the lead in the RSV race, gaining priority review for their RSV candidate in older adults with a May 3, 2023 target action date. The application was supported by impressive data from the AReSVi-006 trial, showing the vaccine to be highly effective in providing protection against RSV-associated lower-respiratory tract diseases in adults aged 60 and over.
In December 2022, Pfizer received priority review for their vaccine candidate, with an action date set for May 2023. The Phase III RENOIR study provided evidence of an impressive 87.5% efficacy in adults aged 60 or over, cementing Pfizer’s status as a frontrunner in the battle against COVID-19.
Pfizer and GSK are locked in a race to be the first to bring an RSV vaccine to the market. Both pharmaceutical giants are striving to be the one to offer this important breakthrough, with the winner being determined by who can be the most effective in their research and development.