The Center for Drug Evaluation (CDE) website indicates that France major Sanofi’s (NASDAQ: SNY) Dupixent (dupilumab), Sino-US biotech LianBio’s mavacamten, and Anhui Wotai Bio-pharmaceutical Co., Ltd’s sodium benzoate and sodium phenylacetate are on course to obtain priority review statuses. This development highlights the potential of these drugs to address significant unmet medical needs and expedite their availability to patients.
Dupixent: Monoclonal Antibody for Atopic Dermatitis
Dupixent, a monoclonal antibody (mAb) inhibiting IL-4 and IL-13, has been approved to treat moderate and severe atopic dermatitis in various age groups in China. The intended indication for priority review is prurigo nodosa in adults. This priority review status could accelerate the drug’s availability for this specific indication, offering relief to patients suffering from this debilitating condition.
Mavacamten: First-in-Class Small-Molecule Drug for Hypertrophic Cardiomyopathy
Mavacamten is a first-in-class small-molecule drug that reversibly binds to myosin to target the excess contractility and impaired relaxation underlying hypertrophic cardiomyopathy (HCM). The targeted indication is for use in adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve exercise ability, New York Heart Association (NYHA) cardiac function grading, and symptoms. This priority review status underscores the drug’s potential to significantly improve patient outcomes in HCM.
Sodium Benzoate and Sodium Phenylacetate: Targeting Acute Hyperammonemia
Sodium benzoate and sodium phenylacetate, originated by Bausch Health US LLC, were approved for marketing in the US in February 2005. These drugs, not yet available in China, target acute hyperammonemia and related encephalopathy caused by deficiency of urea circulating enzyme in children and adults. The priority review status for these drugs in China could expedite their introduction, providing a much-needed treatment option for patients with this rare and serious condition.
Strategic Implications
The priority review statuses for Dupixent, mavacamten, and sodium benzoate/sodium phenylacetate reflect the CDE’s commitment to accelerating the approval of innovative therapies. These drugs have the potential to significantly improve patient outcomes and address significant unmet medical needs in their respective therapeutic areas. For Sanofi, LianBio, and Wotai, these priority reviews are strategic milestones that could enhance their market presence and contribute to the global advancement of healthcare.-Fineline Info & Tech
