The FDA granted approval to Shire’s Vyvanse (lisdexamfetamine) as a treatment for attention deficit hyperactivity disorder (ADHD) in pediatric patients ages 6-12. Shire hopes the drug, which is harder to abuse than older stimulants, will revitalize the company’s ADHD franchise, once Adderall XR begins facing generic competition in 2009. Adderall XR brought in approximately $975 million in sales for Shire in 2005, followed by McNeil Consumer and Specialty Pharmaceuticals’ Concerta with sales of $838 million and Eli Lilly’s Strattera, with sales of $662 million. Shire developed Vyvanse in conjunction with New River Pharmaceuticals of Radford, VA. Shire acquired New River in a deal worth $2.6, earlier this month.
Eli Lilly has launched what it has dubbed the first insulin pen with memory, HumaPen Memoir, designed to meet the needs of people with diabetes who take several shots of mealtime insulin each day. Lilly also said it will launch an insulin pen that delivers Humalog in smaller increments, HumaPen Luxura HD, in April 2007. Luxura HD is a reusable pen that can deliver from one-to-30 units of Humalog in half-unit increments, beginning after the first unit. This type of pen may be attractive to people with diabetes that do not need large amounts of insulin, or parents of some children with diabetes, Lilly said.
The FDA has requested that Genentech add a black box warning – the strongest warning possible – to the product label for its asthma drug Xolair (omalizumab). The boxed warning should emphasize that Xolair, used to treat patients with asthma related to allergies, may cause anaphylaxis – a severe allergic reaction – which may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat. In addition, FDA has asked Genentech to revise the Xolair label and provide a medication guide for patients to strengthen the existing warning for anaphylaxis. Despite the FDA’s request, Genentech said in published reports, that a final decision had not been made and that the company was still discussing the matter with the FDA. “The updated wording and its placement in the label is not yet final,” Genentech said in a statement. Xolair was approved in the US in 2003 to treat allergy-related asthma in adults and adolescents (12 years of age and above).Continued reports of anaphylaxis in the post-marketing experience led to the black box warning, the agency said. The strengthened warning includes the possibility of a patient developing anaphylaxis after any dose of Xolair, even if there was no reaction to the first dose. Also, anaphylaxis after administration of Xolair may be delayed up to 24 hours after the dose is given. Health care providers should be prepared to manage life-threatening anaphylaxis following Xolair administration and observe patients for at least two hours after an injection, the FDA said. Following administration of Xolair, patients should also carry and know how to initiate emergency self-treatment for anaphylaxis. Genentech and Tanox have been working with Novartis to develop and market Xolair in the US, which saw domestic sales of approximately $108 million in the third quarter of 2006. In November, Genentech announced plans to purchase Tanox in an effort to maximize its income from Xolair.
Novartis maintains control of Xolair outside the US.
The FDA has approved Eli Lilly’s Cymbalta (duloxetine) for generalized anxiety disorder. Cymbalta is already approved for depression and nerve pain in diabetes patients. Cymbalta sales reached $1.32 billion in 2006, a 94 percent increase over the previous year.
Roche has suspended enrollment in a clinical trial of its experimental anemia drug Cera in anemic lung-cancer patients because of an imbalance of deaths across the four arms of the study, according to a published report.