FDA Approvals Roundup: Klisyri and Ocrevus

RoundupsRoundups | 16 December 2020 |  By 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approval
Klisyri approved as topical therapy for actinic keratosis
Almirall’s Klisyri (tirbanibulin ointment) has been approved as a topical, self-administered treatment for actinic keratosis (AK) of the face or scalp.
The novel, first-in-class microtubule inhibitor is notable for its short treatment protocol of a once-daily application for 5 days and its strong efficacy and safety profiles, as demonstrated by findings from the KX01-AK-003 and KX01-AK-004 studies, according to a press release from the company.
Actinic keratosis (AK) is a chronic, precancerous skin disease occurring primarily on sun-exposed areas of the skin, such as the face, ears, lips, bald scalp, forearms, upper hands, and lower legs. Early diagnosis and intervention are important because the condition can progress, with about 10% of AKs progressing to squamous cell carcinoma.
The randomized, double-blind, vehicle-controlled Phase 3 KX01-AK-003 and KX01-AK-004 studies included 702 patients with AK from centers across the US randomized 1:1 to receive the study drug or vehicle. Primary endpoint in both studies was 100% clearance of the AK lesions in the treatment area at day 57. In KX01-AK-003, 44% of treated patients achieved complete clearance by day 57, compared with 5% of vehicle patients; in KX01-AK-004, 54% versus 13%, respectively, achieved complete clearance. The findings also demonstrated the therapy’s safety, with no patients withdrawing from the study because of adverse events.
Spain-based Almirall entered into a strategic partnership with US-based Athenex in December 2017 to develop and market Klisyri in the US and Europe, including Russia. Athenex conducted the pre-clinical and clinical studies required for the FDA approval, while Almirall will support the development and lead regulatory efforts in the EU.
New dosage and administration
Ocrevus okayed as shorter infusion time formulation for multiple sclerosis
Roche’s Ocrevus (ocrelizumab) has been approved as a shorter, 2-hour infusion time therapy for patients with relapsing or primary progressive multiple sclerosis who have not had previous serious infusion reactions (IRs).
Twice-yearly administration of the humanized monoclonal antibody was previously approved for 3.5 hours infusion time. The initial dose is administered as two 300-mg infusions, 2 weeks apart; subsequent doses are 600 mg, every 6 months.
Ocrevus’ approval was based on findings from the randomized, double-blind ENSEMBLE PLUS study showing similarity between the safety profiles for the 2-hour and 3.5-hour infusion times. The primary endpoint for the ENSEMBLE PLUS study was the proportion of patients with IRs, based on reaction frequency and severity during and 24 hours after infusion. In all, 24.6% of patients receiving the 2-hour infusion had IRs, compared with 23.1% of those on the 3-hour infusion time. IR severity was also similar between the two groups, with 98% of cases resolved in both groups.
Multiple sclerosis is a disabling relapsing or progressive immune-mediated neurologic disease. As a humanized monoclonal antibody, Ocrevus targets a specific type of immune cell thought to a driver of the myelin nerve cell damage that is a hallmark of multiple sclerosis.


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Tags: FDA, US

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