Genentech Issues Dear Healthcare Provider Letter Regarding a2nd Case of PML in a Raptiva Patient
South San Francisco, Calif. -- November 17, 2008 -- Genentech, Inc. (NYSE: DNA) announced today that the company has issued a Dear Healthcare Provider letter to inform dermatologists and neurologists of a 2nd case of progressive multifocal leukoencephalopathy (PML) which resulted in the death of a 73-year old woman who had received Raptiva® (efalizumab) for approximately four years for treatment of chronic plaque psoriasis. Based on the medical information available for the two cases of PML, which occurred in one 70-year old patient and one 73-year old patient who received Raptiva for approximately four years, Genentech believes that Raptiva likely increases the risk of PML and that prolonged exposure to Raptiva and older age may further increase this risk. The company is working with the U.S. Food and Drug Administration (FDA) to determine the appropriate next steps.
The Raptiva prescribing information was updated in October 2008 to include a boxed warning on the risk of serious infections, including PML in patients receiving Raptiva. A Dear Healthcare Provider letter was issued in early October to inform healthcare providers of the first reported case of PML. This second case of PML in a Raptiva-treated patient was recently reported to the company in late October as part of Genentech's ongoing safety monitoring and surveillance program.
"Given the seriousness of PML and its rarity in the general population, it is important to inform healthcare providers of this second reported case in a Raptiva-treated patient, so that physicians and their patients are equipped to make informed treatment decisions," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer.
Patients who are currently on Raptiva therapy or considering Raptiva should discuss the benefits and risks of Raptiva with their physicians. As described in the Raptiva package insert, some patients have had severe worsening or new forms of psoriasis while taking Raptiva or after stopping Raptiva. It is important for patients to talk with their physician before changing or stopping their treatment.
The Dear Healthcare Provider letter has been posted to the Genentech web site and is available along with the current package insert including Raptiva safety information by clicking the Raptiva link at http://www.gene.com/gene/products.
PML is a rare, progressive, demyelinating disease of the central nervous system that usually leads to death or severe disability. PML is caused by activation of the John Cunningham, (JC) virus. JC virus resides in latent form in up to 80 percent of healthy adults, typically only causing PML in immunocompromised patients. The factors leading to activation of the latent infection are not fully understood, though abnormalities in T cells may be important for reactivation and PML. PML has been reported in the published literature in HIV-positive patients, as well as immunosuppressed cancer patients (including patients with hematologic malignancies), organ transplant recipients, and patients with autoimmune diseases. There are no known interventions that can reliably prevent or adequately treat PML.
Psoriasis occurs when new skin cells grow abnormally, resulting in thick, red, and scaly, inflamed patches. Plaque psoriasis, the most common form of the disease, affects approximately 2.3 million Americans and is characterized by inflamed patches of skin ("lesions") topped with silvery white scales. Psoriasis can be limited to a few spots or involve extensive areas of the body, appearing most commonly on the scalp, knees, elbows and trunk. Although it is highly visible, psoriasis is not a contagious disease. While there are a number of medications that may help control the symptoms of psoriasis, there currently is no known cure.
Raptiva® (efalizumab) is a humanized therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that lead to the development of psoriasis. In October 2003, Raptiva received U.S. Food and Drug Administration approval for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy. Raptiva can be self-administered by patients as a single dose, once-weekly, subcutaneous injection after proper training by a healthcare professional.
Important Safety Information
The most serious adverse reactions observed during treatment with RAPTIVA include serious infections leading to hospitalization or death and progressive multifocal leukoencephalopathy (PML), malignancies, immune-mediated thrombocytopenia, immune-mediated hemolytic anemia, arthritis events, psoriasis worsening and variants, and neurologic events. Serious infections and immune-mediated thrombocytopenia have been reported during post-marketing surveillance. Physicians should follow patients for signs and symptoms of thrombocytopenia; platelet monitoring is recommended. Live and live-attenuated vaccines should not be administered during Raptiva treatment.
The most common adverse reactions associated with Raptiva were a symptom complex that included headache, chills, fever, nausea, and myalgia within 48 hours following the first 2 injections. These events were largely mild to moderate when a first dose of 0.7 mg/kg was given. Less than 1 percent of patients discontinued Raptiva treatment because of these adverse events.
For full prescribing information, please visit http://www.RAPTIVA.com or call 877-RAPTIVA.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with significant unmet medical needs. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.
Posted: November 2008
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