US Patent

US11433059 — BYL719 (alpelisib) for use in the treatment of PIK3CA-related overgrowth spectrum (pros-CLOVES syndrome)

Method of Use · Assigned to Assistance Publique Hopitaux de Paris APHP · Expires 2037-02-17 · 11y remaining

Vulnerability score 75/100 Vulnerable — likely target for IPR or design-around

What this patent protects

This patent protects the use of BYL719 (alpelisib) for treating PIK3CA-Related Overgrowth Spectrum (PROS) and Congenital, Lipomatous, Overgrowth, Vascular Malformations, Epidermal Nevi and Spinal/Skeletal Anomalies and/or Scoliosis (CLOVES) syndrome.

USPTO Abstract

The present invention relates to a method of treating PIK3CA-Related Overgrowth Spectrum (PROS) more particularly, Congenital, Lipomatous, Overgrowth, Vascular Malformations, Epidermal Nevi and Spinal/Skeletal Anomalies and/or Scoliosis (CLOVES) 10 syndrome. To date, there are no specific treatments for patients and no animal models of PROS to better understand the physiopathology of the disorder. Inventors developed a genetic mouse model of PROS that recapitulates the human disease and demonstrated the efficacy of BYL719. Based on these results they treated two patients, one adult and one child, with severe CLOVES syndrome using BYL719. The drug had a robust efficiency on disease in the 15 two patients inducing quick recovery of all affected organs. Thus, the invention relates to a method of treating PROS in a subject in need thereof comprising the step of administrating the subject with a therapeutically effective amount of BYL719.

Drugs covered by this patent

FDA Patent Use Codes

When a patent is method-of-use, FDA lists it once per applicable indication ("U-code"). Each U-code carves out a specific therapeutic use that generic filers must either license or design around.

CodeDescriptionDrug
U-4359 Piqray
U-4359 Piqray
U-4359 Piqray
U-4359 Piqray

Patent Metadata

Patent number
US11433059
Jurisdiction
US
Classification
Method of Use
Expires
2037-02-17
Drug substance claim
No
Drug product claim
No
Assignee
Assistance Publique Hopitaux de Paris APHP
Source
FDA Orange Book + USPTO grounding via Google Patents

Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.

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