Novartis Receives FDA Approval for New Oral Granule Formulation of PI3Kα Inhibitor Vijoice (Alpelisib)
Novartis
Drug Development and Manufacturing
Source: PharmaCube Info
Vijoice tablets are available in three strengths: 50mg, 125mg, and 200mg, while the granule formulation is 50mg per sachet. The prescribing information indicates that the most appropriate formulation can be chosen based on the required dosage and patient needs, but tablets and granules should not be taken together to achieve the prescribed dose. The granule formulation is more suitable for patients who have difficulty swallowing tablets and is also convenient for patients who only need to take 50mg daily. It should be noted that if the prescribed dose is 125mg or 250mg, patients should not combine multiple sachets of 50mg or split a single sachet for use.
Alpelisib is a PI3Kα inhibitor that was first approved by the FDA on 2019/5/24, with the brand name Piqray. Its indication is: in combination with fulvestrant for the treatment of postmenopausal women and men with HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer as detected by the FDA, making it the first treatment targeting PIK3CA mutations in HR+/HER2- advanced breast cancer.
In April 2022, alpelisib was approved by the FDA for a new indication,For the treatment of severe PIK3CA-Related Overgrowth Spectrum (PROS),Requiring systemic treatmentAdults and 2 years of age and abovePediatric patients, brand nameVijoice, this is the indication for the granule formulation in this update.
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