FDA committee recommends approval of Abbott’s Trilipix, statin combination
ABBOTT PARK, Ill. — A Food and Drug Administration advisory committee has voted to recommend that the FDA retain approval of an Abbott drug for high cholesterol in combination with a statin.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met Thursday to discuss whether to recommend continued FDA approval of Trilipix (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia and a high risk of heart disease. The FDA is not bound by advisory committee votes, but usually follows them.
Results from the “ACCORD Lipid” study had raised concerns about the safety and efficacy of combining the drug with a statin, showing no significant difference between patients treated with Trilipix and simvastatin versus those treated with placebo and simvastatin, and an analysis of the data indicated that women who took the combination experienced more heart attacks than those in the placebo group, but the clinical significance of the finding was unclear at the time.
“Abbott appreciates the committee’s recognition that the totality of data, including ‘ACCORD Lipid,’ supports retaining the co-administration indication for Trilipix in appropriate patients,” Abbott VP global pharmaceutical clinical development Eugene Sun said. “We also appreciate the request for more clinical data and look forward to further discussions with the FDA.”
Louisiana seeks to expand pharmacy’s ability to immunize patients
ALEXANDRIA, Va. — The Louisiana State Senate passed legislation that would expand the authority given to pharmacists to administer immunizations.
State Sen. Fred Mills Jr., R-22, who serves on the Senate Health and Welfare Committee, is the author of SB 60, which would expand pharmacists’ authority to provide immunizations to Louisianans ages 18 years and older against pneumonia, shingles, tetanus, diphtheria and pertussis without a prescription.
"The pharmacists of Louisiana are to be commended for the final senate passage of SB 60, which will enable pharmacists to immunize more patients," Mills said. "As one of the most trusted professions, pharmacists provide high-quality and accessible care to patients. We are pleased with this victory and urge the House to move swiftly to also pass this legislation, and send to the governor to be signed into law."
The legislation is expected to be voted on as early as next week by the Louisiana House of Representatives.
The National Association of Chain Drug Stores on Friday applauded the passage, stating that the bill would help prevent 14 million cases of disease and 33,000 deaths annually.
"Pharmacies are the face of neighborhood healthcare, providing cost-effective, easily accessible and convenient services, such as immunizations," stated NACDS president and CEO Steve Anderson. "Pharmacists have the ability to immunize in all 50 states, reducing costs for both patients and the overall healthcare delivery system."
Many Americans remain unvaccinated and susceptible to vaccine-preventable diseases. An Institute of Medicine report estimated that more than 50,000 adults and 300 children in the United States die each year from vaccine-preventable diseases or their complications.
Anderson added, "Enabling pharmacists to provide important vaccine services to more Americans will serve important public health goals by providing a convenient and cost-effective option for receiving the recommended vaccines and immunizations. Expanding immunization authority is an excellent use of pharmacists, who are highly educated healthcare professionals."
To sit for pharmacy board licensure exams, candidates must have a Doctor of Pharmacy degree (PharmD), which requires a minimum of six years of professional education.
Sandoz looks to market generic Vyvanse
DUBLIN — Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.
Shire said Thursday that it received a notice letter from Sandoz, the generics division of Swiss drug maker Novartis, that the latter had filed a regulatory approval application with the Food and Drug Administration for a generic version of Vyvanse (lisdexamfetamine dimesylate). The application contained a Paragraph IV certification, a legal assertion that the patents covering Vyvanse — all of which expire in 2023, according to the FDA Orange Book — are invalid, unenforceable or won’t be infringed.
Under the Hatch-Waxman Act of 1984, Shire has 45 days in which to review Sandoz’s letter and determine if it will file a patent infringement suit, which would result in the FDA placing a 30-month stay of approval on the generic. In many cases of generic drug companies challenging branded drug patents, however, the generic and branded company will reach a settlement that allows the generic launch to occur before the patents expire.