FDA committee votes unanimously to approve tetrabenazine for Huntington’s chorea
WASHINGTON An advisory committee to the Food and Drug Administration voted unanimously to recommend the approval of tetrabenazine, an investigational compound for the treatment of chorea associated with Huntington’s disease, according to published reports. This would be the first drug approved in the U.S. to treat chorea associated with Huntington’s disease.
HD is a devastating neurodegenerative disease that causes progressive movement disorders, cognitive dysfunction and behavioral changes. Chorea is characterized by excessive, involuntary and repetitive movements, which are the most visible and dangerous manifestations of Huntington disease.
“The advisory committee’s support of tetrabenazine represents an important advancement for Huntington disease patients, caregivers, advocates and physicians who treat this devastating disease,” said George F. Horner III, president and chief executive officer of Prestwick, the company manufacturing the drug. “We are committed to continuing to work with the FDA to secure full approval of tetrabenazine.”
Tetrabenazine has been designated as an orphan drug by the FDA and has been granted fast track status.
Amgen discussing Aranesp label changes
THOUSAND OAKS, Calif.
Biotechnology company Amgen stated late Thursday that it is discussing potential safety updates for its anemia drugs with the Food and Drug Administration.
The drugs are part of a class of drugs called erythropoiesis stimulating agents, or ESAs, used to treat anemia in chemotherapy and kidney-failure patients. They include Aranesp and Epogen, made by Amgen, and Johnson & Johnson’s Procrit.
The FDA’s Oncologic Drugs Advisory Committee will meet during the first quarter as part of its ongoing review for ESA therapies, the company said.
Earlier this year, the FDA issued requirements for stronger warnings on the drugs and asked for additional studies. The FDA issued a black box warning on the drugs, the most critical warning a drug can carry.
Amgen currently is conducting studies to further determine the possible safety risks when patients use their pharmaceuticals.
Additional safety label changes will likely be based on data from a breast cancer patient study and follow-up data from a cervical cancer patient study, Amgen said.
Shares of Amgen fell $2.05, or 3.7 percent, to $53.10 in premarket trading.
Vemics enters agreement to use eRx Network
NANUET, N.Y. Vemics and eRx Network have announced an agreement under which eRx will use Vemics’ iMedicor online, HIPPA compliant Electronic Health Record transport network, which will carry refill requests electronically rather than by fax or phone.
“The proposed solution will eliminate manual processes and reduce costs for eRx Network pharmacy clients,” said Tom Dorsett, president of healthcare solutions for Vemics. “In addition, it will eliminate multiple manual processes for the physician office and take them a step closer to adoption of more profitable e-prescribing technology.”
“This relationship will move physicians quicker to electronic prescribing and help the pharmacy by eliminating the need to data-enter refill responses,” said Murray Lyle, president and chief operating officer of eRx Network. “There is significant room for growth and expansion as this partnership evolves.” eRx Network currently has more than 200,000 active physician subscribers utilizing the network for carrying e-prescribing transactions and prescription refill requests.
The iMedicor portal, which went live on Oct. 10, is the health industry’s first free, HIPAA-compliant online personal health data exchange and secure messaging portal for physician collaboration, community and referrals. The portal’s proprietary HIPAA-compliant technology and ability to enable health providers to exchange medical record data, documentation and images are what distinguishes it from the chat-room-style portals for doctors currently in existence.