Aug 18, 2009
New Brand of Interferon Beta for Treating MS Approved by FDA
Novartis Pharmaceuticals Corporation announced that the U.S. Food and Drug Administration has approved the marketing of Extavia®, its own brand of interferon beta-1b, the same disease-modifying therapy that has been marketed as Betaseron® (Bayer Schering Pharma) since it was approved in 1993 to reduce the frequency of MS exacerbations (attacks or relapses). Like Betaseron, Extavia is taken by every-other-day subcutaneous injections. The release of the same product under a new brand name was made possible through an agreement between Novartis and Bayer Schering. According to Novartis, Extavia will be available by prescription in fall 2009.
Because Extavia is identical to Betaseron, and is produced by the same manufacturer, the company was not required by regulatory agencies to conduct new clinical trials to prove its effectiveness. Like Betaseron, Extavia is approved for the treatment of relapsing forms of MS as well as for use in individuals who have experienced a first clinical episode (clinically-isolated syndrome) and have MRI features that are consistent with multiple sclerosis. Relapsing forms of MS include individuals with secondary-progressive MS who continue to experience relapses or acute attacks. Extavia was approved for marketing in Europe earlier this summer.
According to Novartis, the company is releasing this new brand of interferon beta-1b to begin establishing its presence in the MS community, in advance of other MS drug products it has in its pipeline. No pricing information has yet been released, but the company has stated that it is planning a generous and competitive patient assistance and support program that would encourage its use.
Novartis has established a helpline for consumers and physicians who have questions about Extavia: 866-925-2333
FREQUENTLY ASKED QUESTIONS ABOUT FDA APPROVAL OF EXTAVIA
Q: Why is Novartis releasing a new brand of an established MS therapy?
A: The company has stated that releasing Extavia is the beginning of its efforts to establish a presence in the MS community. Novartis has other products in development for potential use in MS, including its oral drug fingolimod (FTY 720), which is currently in phase III clinical trials.
Q: Is Extavia a generic version of Betaseron?
A: No, Extavia is identical and is produced by the same manufacturer. For this reason, no additional clinical trials of this therapy were required by the FDA.
Q: What will Extavia cost?
A: Novartis will release details of the cost and its patient support programs before the drug becomes available for prescription in October 2009.
Q: Why would a person doing well on Betaseron want to switch to Extavia?
A: Since Extavia is identical to Betaseron, Novartis has stated that its patient support program and costs to the individual will make its brand of interferon beta-1b competitive and attractive to prescribers and patients.
Q: Should I switch from Betaseron to Extavia?
A: That is a question that an individual and his or her prescribing physician should discuss when there are further details available about the cost of Extavia and patient support programs.
Q: Where can I get more information about Extavia?
A: Novartis has established a helpline for consumers and physicians who have questions about Extavia: 866-925-2333. More information will be forthcoming about the therapy's patient support programs and costs.
Betaseron is a registered trademark of Bayer
Extavia is a registered trademark of Novartis