product approval

FDA Approves Myrbetriq Combo Treatment for Overactive Bladder

The Food and Drug Administration (FDA) has approved Myrbetriq (mirabegron extended-release tablets; Astellas) in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. In clinical trials, the combination of Myrbetriq + solifenacin succinate was associated with greater improvements in the number of incontinence episodes per 24 hours (primary endpoint), the number of micturitions per 24 hours (primary endpoint), and the volume voided per micturition (secondary endpoint) compared to placebo or to individual active components. Long-term data also demonstrated that the effects of combination treatment were maintained throughout a 1-year treatment period. Read more.

Source: MPR, April 30, 2018

drugs for overactive bladder (OAB)

Urovant Starts Pursuit of Astellas’ Overactive Bladder Drug Myrbetriq with New Phase 3 Trial

A little later than expected, Roivant group company Urovant has started its confirmatory phase 3 program for overactive bladder (OAB) drug vibegron, originally licensed from Merck & Co.  The pivotal trial—which was originally expected to get underway last year—will involve around 1,400 adults with symptoms of OAB such as urge urinary incontinence, urgency, and urinary frequency, according to Urovant.  The drug already has positive phase 2b and phase 3 data in hand, so if the latest trial is positive Urovant should be able to move ahead with regulatory filings. If approved, it could become a direct competitor to Astellas’ Myrbetriq (mirabegron), the first beta3-adrenergic agonist to reach the market for OAB. And that could present a big commercial opportunity: Astellas reported sales of its drug rose 30% to 93.1 billion yen ($876 million) in the nine months to end-January 2018 with take-up driven by greater tolerability than the widely used antimuscarinic OAB drug class. Read more.

Source: Fierce Biotech, March 28, 2018

drugs for overactive bladder (OAB)

U.S. FDA Accepts for Review Astellas sNDA for Mirabegron

Astellas Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The anticipated Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 28, 2018. In the United States, mirabegron and solifenacin succinate are marketed as Myrbetriq® and VESIcare®, respectively. Each is approved by the FDA as a monotherapy for the treatment of OAB with symptoms of urge urinary continence, urgency and urinary frequency. Read more.

Source: Gurufocus.com, September 12, 2017

business buildings

Astellas Submits Supplemental New Drug Application for Mirabegron

Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. In the United States, mirabegron and solifenacin succinate are marketed as Myrbetriq® and VESIcare®, respectively. Each is approved by the FDA as a monotherapy for the treatment of OAB with symptoms of urge urinary continence, urgency and urinary frequency.  Read more.

Source: PRNewswire, June 29, 2017