FDA approves Kuvan for treatment of PKU
WASHINGTON The Food and Drug Administration has approved Kuvan, by BioMatrin Pharmaceuticals, as the first drug to be approved to slow the effects of Phenylketonuria, a rare genetic disorder that causes mental retardation, smaller brain size, delayed speech and other neurological problems.
PKU is a genetic disorder in which the enzyme phenylalanine hydroxylase, which helps the human body break down phenylalanine, an amino acid found in foods, does not function properly. The result is high levels of phenylalanine in the blood. High levels of phenylalanine hydroxylase are toxic to the brain and can lead to mental retardation, behavioral abnormalities, seizures, an inability to focus and organize information, and other neurologic complications.
Kuvan works by increasing phenylalanine hydroxylase enzyme activity in PKU patients with some residual phenylalanine hydroxylase enzyme function. This then leads to an increased breakdown of phenylalanine, resulting in lower levels of phenylalanine in the blood.
Kuvan must be used in combination with a phenylalanine-restricted diet. A patient can override the effects of Kuvan by not following such a regimen. Phenylalanine is present in foods that contain proteins such as meats, dairy and egg products, as well as diet sodas containing aspartame.
Patients being treated with Kuvan must have their blood phenylalanine levels monitored frequently by their physicians or other health care professional to ensure their phenylalanine levels are in the normal range. The FDA also recommends patients work closely with a dietitian to manage their diets. In addition, the manufacturer will establish general disease registries for PKU to help the FDA and physicians track how patients are doing on the medication around the world in order to monitor its safety, efficacy and any adverse events.
FDA grants Mylan tentative approval for generic Lamictal
PITTSBURGH, Pa. Mylan Pharmaceuticals has received tentative approval from the Food and Drug Administration for a generic version of Lamictal.
Lamictal, by GlaxoSmithKline is used to treat epilepsy and bipolar I disorder. The generic version, lamotrigine, will be available in 25 mg, 100 mg, 150 mg and 200 mg tablet strengths.
The drug had sales of about $1.97 billion for the 12 months ended Sept. 30, 2007.
NoMoreClipboard.com, ReliefInsite.com partner to offer online pain management module
FORT WAYNE, Ind. NoMoreClipboard.com and ReliefInsite.com have teamed up to ease pain management for patients, practitioners and caregivers. The two have incorporated a free pain management module into the NoMoreClipBoard.com interface.
NoMoreClipboard.com, an online personal health record company, works with health care providers and industry groups to simplify transactions between patients, providers and payors, saving each party significant time and effort. Within NoMoreClipboard.com, patients or caregivers can store information such as allergies, medications and medical conditions in a secure environment. The patient can then choose to share their records with selected health care providers, and NoMoreClipboard.com takes care of securely transferring the record to physicians on behalf of the patient. ReliefInsite.com is a health care information technology company that provides secure online pain management services.
The ReliefInsite.com pain management module within NoMoreClipboard.com allows patients to share their daily pain diary with doctors, nurses, therapists, family members and friends. In addition, ReliefInsite.com offers dynamic, real-time graphical reports to help improve patient compliance, and assists case managers by monitoring therapy effectiveness with time-stamped records, revealing the interaction between pain levels and the patient’s personal and professional lifestyle.
“NoMoreClipboard.com allows patients to store and manage health information and share it with their health care providers, easily and seamlessly,” said Jeff Donnell, NoMoreClipboard.com vice president of marketing. “The ReliefInsite pain management module makes our personal health record even more valuable for the 50 million Americans who currently suffer from chronic pain.”