IHS Global Insight Perspective | |
Significance | The withdrawal is to be carried out in a phased manner and follows a U.S. FDA advisory in February, this year. The development is linked to the product's association with increased risk of progressive multifocal leukoencephalopathy. |
Implications | Marketing of Raptiva was suspended in Europe two months ago, followed by similar regulatory decisions banning the product in the United Arab Emirates, Singapore, and Malaysia. Hence, such a development was anticipated in the United States as well. |
Outlook | The voluntary withdrawal is likely to trigger some legal challenges as patients are weaned off the drug. The financial impact of this move is not expected to be significant to Genentech's parent company Roche's projections for 2009. |
Raptiva Withdrawal
Two months after the European Medicines Agency (EMEA) recommended a suspension of marketing of psoriasis drug Raptiva (efalizumab), drug maker Genentech announced the voluntary withdrawal of the drug from the U.S. market in a phased manner. Raptiva is approved in the United States as a treatment for chronic moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The move will affect 2,000 patients in the United States receiving Raptiva for chronic plaque psoriasis. The phased withdrawal will see the product disappear from the pharmacy shelves completely from 8 June 2009.
The decision involves the increasing risk of progressive multifocal leukoencephalopathy (PML) attached to the drug. Three cases of PML have been reported in patients receiving Raptiva, and one case of death after the patient developed progressive neurologic symptoms. However, the European regulatory body EMEA's Committee for Medicinal Products for Human Use (CHMP) associated the product with other side effects including Guillain-Barré syndrome, Miller Fisher syndrome, encephalitis, encephalopathy, meningitis, sepsis, and opportunistic infections in its risk-benefit review analysis earlier this year.
In the United States, the product labelling has gone through two updates since October 2008, when the first PML case was reported along with a black box warning and an official medication guide for patients. The U.S. FDA also requested Genentech submit a Risk Evaluation and Mitigation Strategy (REMS) for the product. However, the regulatory body has stopped short of issuing a suspension, instead providing a public health advisory to healthcare professionals and consumers on the increased risks associated with the product. The advisory also contained information on recognition of PML symptoms and suggested physicians increase monitoring of patients receiving Raptiva.
Raptiva is developed and marketed by Genentech in the United States, and the product has been licensed to Merck Serono (Germany) to market in Japan and worldwide (outside the United States). The product has garnered U.S. sales of US$108 million for 2008. Genentech has indicated that it will be reporting a one-time cost of sales charge of US$125 million in its first-half financial results for 2009.
Outlook and Implications
The voluntary withdrawal of Raptiva is a setback for Genentech. The move was to an extent anticipated following the suspension and ban prohibiting the marketing of the product in the European Union and in smaller markets in the Middle East and South-East Asia. Genentech has confirmed that the decision to pull the drug was taken after consultation with the FDA, indicating that the regulatory agency's risk-benefit analysis, initiated just after the European ban, may have been an influencing factor. The FDA's actions relating to the product's risks have followed an expected course, with earlier black-box warnings and the REMS. But the European suspension is likely to have provided the impetus for Genentech considering the withdrawal.
Genentech has, however, maintained that the decision reflected the firm's commitment to patient safety, and noted that the balance between benefit and risk in the psoriasis population has significantly changed. This suggests that the regulatory agency may have taken into account the presence of other treatments in the market since the launch of Raptiva which have demonstrated a better safety record than the product. Other treatments approved to treat psoriasis in the United States include Enbrel (etanercept; Wyeth/Amgen; U.S.), Fumaderm (fumaric acid esters; Biogen Idec; U.S.) and Neoral (cyclosporin; Novartis; Switzerland).
The impact of the withdrawal is not expected to be significant in terms of financials for Genentech. Raptiva is an important brand for the firm, but does not feature in the top-five drugs in terms of sales for the U.S. firm. But given the increasing concerns over drug safety in the United States, the firm can expect some legal challenges from patients who have been receiving Raptiva. While the FDA had indicated that the Office of Surveillance and Epidemiology has reported some cases of adverse events relating to the drug in late 2008, there is no clarity over whether the number of cases could exceed more than the four mentioned by the FDA and Genentech in their statements.
Related Articles
- Singapore - Germany: 6 March 2009: Merck Serono's Raptiva Banned in Singapore
- United Arab Emirates: 2 March 2009: U.A.E. Bans Raptiva Post Europe Ban
- Germany - United States: 20 February 2009: PML Risk Prompts Suspension of Raptiva's European Marketing
- United States: 18 November 2008: Genentech to Work with FDA on Raptiva Labelling Following Second PML Case