Drug for rare, fatal genetic disorder receives FDA approval
SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for a genetic disorder that affects about 500 people in the United States and 3,000 worldwide, the agency said Tuesday.
The FDA announced the approval of Procysbi (cysteamine bitartrate) delayed-release capsules, made by Novato, Calif.-based Raptor Pharmaceuticals, for cystinosis. Cystinosis causes buildup in every cell of the body of a protein building block called cystine, which can cause kidney problems and thus lead to excess loss of sugar, proteins and salts through the urine. Cystinosis may lead to slow body growth and small stature, weak bones and kidney failure and is fatal if not treated in early childhood. The most severe of the three types of the disease is nephropathic cystinosis, which causes severe kidney damage.
The FDA has approved two other drugs for cystinosis: Mylan’s Cystagon (cysteamine bitartrate), approved in 1994; and Sigma-Tau Pharmaceuticals’ Cystaran (cysteamine) ophthalmic solution eye drops, used to treat corneal cystine crystal accumulation, approved last year.
Syneron Beauty introduces Pearl system for at-home teeth whitening
NEW YORK — Syneron Beauty has announced the launch of the Pearl Brilliant White Ionic Teeth Whitening system, which according to the manufacturer, features its patented ionic technology — the first new at-home teeth whitening technology to be cleared by the FDA in more than a decade.
In a clinical study, the system was shown to provide maximum whitening results of up to 10 shades after 50 minutes of treatment with virtually no sensitivity, the company stated.
The device uses a micro-current to activate Pearl’s Ionic Whitening Gel, allowing it to penetrate deep within the enamel to erase years of embedded stains without sensitivity or irritation, according to the company. Clinical studies reportedly indicate that using Pearl’s ionic technology delivers double the maximum whitening results by 100%, compared with non-ionic whitening treatments.
Pearl provides whitening with a double-biting, hands-free mouth tray that is designed to treat the front, back, top, bottom and in between the teeth. Both Brilliant White and Gentle White kits include the Pearl mouthpiece and 20 gel tubes of the Ionic Whitening Gel.
The recommended protocol is to treat for five minutes, twice daily, for five days (10 treatments total). It is recommended to use a Pearl Ionic Whitening Gel Booster Kit (available in Gentle and Brilliant formulas) every three months or as needed.
Syneron Beauty entered the oral care category last year with the introduction of the Tanda Pearl Ionic Teeth Whitening System. With new clinical study data on the efficacy of ionic technology and solutions in the category, Syneron Beauty created the Pearl brand, focused solely on adding new innovation to its portfolio of cosmetic oral care products.
Pearl Ionic Teeth Whitening Systems, Brilliant White and Gentle White, became available in April at such prestige beauty retailers as Ulta Beauty.
FDA approves Genentech arthritis drug for rare disorder in children
SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug made by Genentech for a rare form of arthritis in children, the company said Tuesday.
Genentech, a subsidiary of Swiss drug maker Roche, announced the approval of Actemra (tocilizumab) for polyarticular juvenile idiopathic arthritis in children ages 2 years and older, either alone or combined with the generic drug methotrexate.
"Polyarticular juvenile idiopathic arthritis is a rare, debilitating condition in children that worsens over time," Genentech chief medical officer and head of global product development Hal Barron said. "We are pleased to offer Actemra to doctors and patients ages 2 years and older as an important medicine to help improve signs and symptoms of this often painful disease."