Novartis said that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for brolucizumab (RTH258) as a potential treatment for wet age-related macular degeneration (AMD).
The company said that it used a priority review voucher to fast track the review of the regulator on brolucizumab in order to make it available to patients as quickly as possible.
Novartis expects the drug to be launched by the year end should it be approved by the FDA.
Novartis Pharmaceuticals president Fabrice Chouraqui said: “Reaching this milestone is an important step in our efforts to reimagine the treatment journey for people with wet AMD and their caregivers.
“We are looking forward to the potential of a new option for patients with wet AMD, who often have to navigate considerable physical and emotional difficulties caused by deteriorating vision.”
The BLA for brolucizumab is mainly based on the findings of the HAWK and HARRIER phase 3 trials, which featured more than 1,800 patients. The Novartis drug met the primary efficacy objective of non-inferiority compared to aflibercept in mean change in best-corrected visual acuity (BCVA) from baseline to week 48 by demonstrating high statistical significance.
In addition, brolucizumab showed superiority in three secondary endpoints – central subfield retinal thickness, retinal fluid and disease activity, which are considered key parameters of nAMD.
According to Novartis, brolucizumab is a humanized single-chain antibody fragment (scFv), whose innovative structure is claimed to result in a small molecule (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms.
In a separate development, the Swiss pharma company announced that the WANECAM 2 collaboration, of which it is a member, has secured new funding of €10m over five years from the European & Developing Countries Clinical Trials Partnership (EDCTP) to develop a next-generation antimalarial drug.
WANECAM 2 is a partnership between Novartis, antimalarial drug researchers in Africa and Europe from ten academic institutions, and Medicines for Malaria Venture.
The funding is expected to support late-stage clinical trials of an antimalarial combination that comprises KAF156 (ganaplacide) and lumefantrine in a new once-daily formulation. The trials will be held in Burkina Faso, Gabon, Mali and Niger.