Abbott: LCIG may improve Parkinson’s disease symptoms among patients
ABBOTT PARK, Ill. — Patients with Parkinson’s disease treated with an investigational drug made by Abbott saw a decrease in the amount of time their symptoms resurfaced, while the time in which their symptoms stayed under control increased, according to results of a late-stage clinical trial that Abbott announced Thursday.
The 192-patient trial was a 54-week, phase-3 study of levodopa-carbidopa intestinal gel, or LCIG. As Parkinson’s patients’ disease progresses during treatment with oral medications, they usually will experience “off” time, when some of their symptoms re-emerge. This contrasts with “on” time, when their symptoms are well-managed. They also may experience involuntary movements associated with most treatments used to manage the disease, known as dyskinesias, which can result from spikes in drug levels in the blood caused by inconsistent absorption of oral medications.
After 12 weeks of therapy, patients reported an average of 3.9 fewer hours of “off” time and 4.6 more hours of “on” time without troublesome dyskinesias.
LCIG is infused with a portable pump directly into the small intestine via a small tube during daytime hours, and continuous delivery may help reduce drug-level spikes, thus reducing dyskinesias.
FDA approves labeling change for Eli Lilly insulin product
INDIANAPOLIS — Patients with Type 1 diabetes using an insulin product made by Eli Lilly can store it in their pumps for longer periods of time, while children using it have additional options, thanks to a labeling change approved Wednesday by the Food and Drug Administration.
The FDA approved changes to the labeling of Humalog (insulin lispro [rDNA origin]) that allows continuous insulin infusion pump therapy in children ages 4 years and older with Type 1 diabetes. Additionally, the insulin can remain in the external pump reservoir for seven days, and patients now can wait three days before changing the infusion set and infusion set insertion site, Lilly said.
“Insulin pumps can be an additional option for people using rapid-acting insulin, and allow people to manage their Type 1 diabetes around their lifestyle,” Lilly clinical research physician Dana Hardin stated. “These Humalog label updates reflect Lilly Diabetes’ commitment to providing people with personalized solutions that meet their everyday needs.”
Court vacates Amylin restraining order against Eli Lilly
INDIANAPOLIS — A federal court has ruled in favor of drug maker Eli Lilly in a dispute with Amylin Pharmaceuticals over Lilly’s partnership with German drug maker Boehringer Ingelheim.
The U.S. District Court for the Southern District of California vacated a temporary restraining order Wednesday that it granted to Amylin last month. Amylin had sought to prevent Lilly from using the same staff to market Tradjenta (linagliptin), an oral treatment for Type 2 diabetes that it developed with Boehringer Ingelheim, that it used to market Byetta (exenatide), an injected Type 2 diabetes drug that it markets under a partnership with Amylin. The restraining order would also have affected Bydureon, a long-acting form of Byetta currently under review by the Food and Drug Administration.
“We are pleased with the court’s decision to vacate the temporary restraining order and deny Amylin’s request for a preliminary injunction,” Lilly SVP and general counsel Robert Armitage stated. “We have complied with our contractual obligations under our agreements with Amylin and done so in a manner fully consistent with all applicable laws.”
Amylin filed suit against Lilly on May 16, alleging that Tradjenta would compete directly against Byetta and Bydureon, and that Lilly thus had violated its contractual agreement with Amylin. While both drugs treat Type 2 diabetes, Lilly responded at the time by pointing out that the two drugs did not compete because Tradjenta is an orally administered drug while Byetta and Bydureon are injectables.