PHARMACY

FDA approves Novartis drug for tumors in patients with rare genetic disease

BY Alaric DeArment

EAST HANOVER, N.J. — A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

The FDA approved Afinitor (everolimus) tablets for treating the tumors, known as renal angiomyolipomas, in adults with TSC who don’t require surgery. The drug already was approved to treat brain tumors known as subependymal giant cell astrocytoma, or SEGA, in patients with TSC.

The tumors occur in up to 80% of people with the disease, which affects between 25,000 and 40,000 people in the United States. TSC, a genetic disorder, can affect various parts of the body and causes disorders, such as skin lesions, seizures, brain swelling, kidney failure, developmental delays and behavioral problems. Onset typically occurs between the ages of 15 and 30 years, and the tumors can grow large enough to cause severe internal bleeding.

"Renal angiomyolipomas are one of the greatest causes of morbidity and mortality in adult TSC patients and can be one of the most challenging aspects of the disease to treat," Cincinnati Children’s Hospital Medical Center nephrology chairman John Bissler said. "Today marks an important step for the TSC community, as Afinitor is now the only approved medicine to reduce the kidney tumor burden in these patients."


Interested in this topic? Sign up for our weekly DSN Collaborative Care e-newsletter.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

PHARMACY

NACDS announces support of enactment of Minnesota PBM audit legislation

BY Antoinette Alexander

ALEXANDRIA, Va. — The National Association of Chain Drug Stores has expressed its support for enactment of the Pharmacy Audit Integrity Program (HF 1236/SF 973) by Minnesota governor Mark Dayton. The law will establish standards in the pharmacy audit process conducted by pharmacy benefit management companies in the state of Minnesota.

NACDS sent a letter of support to Dayton prior to enactment, emphasizing the importance of this legislation in ensuring transparency in the PBM audit process.
 
“The legislation places reasonable limits and terms on the performance and conduct for pharmacy audits such as PBM notification to pharmacies if the terms of a contract are changed, providing advance notice of an audit so that the pharmacy can have appropriate records and staff available to assist in the audit and setting appropriate limits on the scope, timing, and performance of audits so that audits are not disruptive to pharmacy services,” NACDS president and CEO Steve Anderson stated in the letter. “Importantly, the legislation also places appropriate limits on payment to auditors and conditions on when a PBM may recoup money from the pharmacy, as well as establishes an appeals process for pharmacies to contest audit results.”

NACDS has also hailed the enactment of PBM audit legislation (HB 1490) in Mississippi. Governor Phil Bryant signed the bill into law on April 24, following swift legislative action after the bill was introduced on Feb. 23 by Rep. Eugene Forrest Hamilton. Among other provisions, the law will establish procedures for conducting an audit under the state’s Pharmacy Audit Integrity Act, and authorize monetary penalties to PBMs for noncompliance with the Act.
 
NACDS has endorsed federal legislation that seeks to preserve pharmacy choice for patients and takes additional steps to prevent threats to pharmacy patient care. The bipartisan Pharmacy Competition and Consumer Choice Act — S. 1058 and H.R. 1971, sponsored by Sen. Mark Pryor, D-Ark., and Rep. Cathy McMorris Rodgers, R-Wash., respectively — includes provisions requiring transparency by PBMs in pharmacy audits.


Interested in this topic? Sign up for our weekly Collaborative Care e-newsletter.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

PHARMACY

Mylan, Pfizer, Teva reach deal over generic version of EpiPen

BY Alaric DeArment

NEW YORK — Two companies have settled with Teva over the latter’s efforts to launch a generic version of an emergency treatment for allergic reactions.

Under the agreement, involving Mylan and Pfizer’s Meridian Medical Technologies subsidiary, Teva will be allowed to launch a generic version of EpiPen (epinephrine) auto-injector in June 2015, assuming it wins approval from the Food and Drug Administration. Mylan Specialty markets the EpiPen, which Meridian manufactures.

The companies said the terms of the deal were confidential, and the deal remained subject to review by the Department of Justice. Currently, Teva has not won tentative or final approval from the FDA for its version of the product.


Interested in this topic? Sign up for our weekly DSN Collaborative Care e-newsletter.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES