FDA Approves VESIcare LS™ (solifenacin succinate) Oral Suspension for Pediatric Patients

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May 27, 2020, 14:30 ET

NORTHBROOK, Ill., May 27, 2020 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has approved VESIcare LS™ (solifenacin succinate) oral suspension for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older.

Patients with NDO may experience involuntary bladder contractions, which can lead to symptoms of urinary urgency, frequency and incontinence.¹ Spina bifida, a congenital spinal cord defect, is a common cause of NDO in children.²

"Treatment options for children with neurogenic detrusor overactivity are limited," said Salim Mujais, senior vice president and head, Medical Specialties, Astellas. "As part of Astellas' commitment to advancing treatment options for urologic conditions, we are now able to offer children with NDO a new, non-invasive option."

VESIcare LS is an oral suspension dosage form that was specifically developed to facilitate dosing and administration in the pediatric population.

VESIcare (solifenacin succinate) tablets were initially approved in the United States in 2004. VESIcare LS oral suspension will come in a 5 mg/5 mL (1 mg/mL) oral suspension and will be available in the United States in late 2020. It is also available in Europe.

About VESIcare LS
VESIcare LS™ (solifenacin succinate) is a prescription medicine for children 2 years of age and older with a condition called neurogenic detrusor overactivity. It is used to increase the amount of urine your bladder can hold and reduce urine leakage.

Important Safety Information
VESIcare LS is not for everyone. Do not take VESIcare LS if you have delayed or slow emptying of your stomach (gastric retention), have an eye problem called "uncontrolled narrow-angle glaucoma," or are allergic to solifenacin succinate or any of the ingredients in VESIcare LS.

VESIcare LS may cause serious allergic reactions. If you experience hives, skin rash or swelling; severe itching; swelling of your face, mouth, or tongue; or trouble breathing, stop taking VESIcare LS and get medical help right away. Talk to your doctor right away if you experience headache, confusion, hear voices, see things, or sense things that are not there (hallucinations), or sleepiness. VESIcare LS may cause blurred vision or drowsiness, so use caution while driving or doing unsafe tasks.

Before you take VESIcare LS, tell your doctor if you have any medical conditions, including any stomach or intestinal problems or problems with constipation, trouble emptying your bladder or a weak urine stream, liver or kidney problems, a heart problem called "QT prolongation," are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. Common side effects include constipation, dry mouth, and urinary tract infection. Call your doctor if you get severe stomach area (abdominal) pain or become constipated for 3 or more days.

For further information, please talk to your healthcare professional and see Patient Product Information and complete Prescribing Information for VESIcare LS™.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Astellas
Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information on Astellas, please visit our website at www.astellas.com/us. You can also follow us on Twitter at @AstellasUS, Facebook at www.facebook.com/AstellasUS or LinkedIn at www.linkedin.com/company/astellas-pharma-us/.

Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

¹ Hristov KL, Afeli SAY, Parajuli SP, Cheng Q, Rovner ES, et al. Neurogenic detrusor overactivity Is associated with decreased expression and function of the large conductance voltage- and Ca2+ -activated K+ channels. PLoS ONE 2013;8(7):1-8.
² UCSF_Spina bifida / myelomeningocele / neurogenic bladder (08-06-2015). https://urology.ucsf.edu/sites/urology.ucsf.edu/files/uploaded-files/basic-page/spina_bifida_myelomeningocele_neurogenic_bladder_080615_0.pdf. Accessed 05-11-2020.

SOURCE Astellas Pharma US, Inc.