Extavia (interferon beta-1b) approved for multiple sclerosis

Extavia (interferon beta-1b) has been approved by the FDA for the treatment of multiple sclerosis (MS). It's nice to have other options, right? This drug has been available in Europe, and now it's coming to the U.S.

Here are some interesting facts:

* Extavia is branded version of interferon beta-1b, a standard-of-care for multiple sclerosis in the US for more than 16 years

* MS affects around 400,000 people in US - one of the most common neurological disorders in young adults

* FDA approval marks important step forward for Novartis, laying foundation for innovative approach to treatment of MS

Here are the first few paragraphs from the press release:

Basel, August 17, 2009 - The US Food and Drug Administration (FDA) has approved Extavia® (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease.

Extavia is approved by the FDA for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. The therapy is also indicated for patients who have experienced a first clinical episode of MS and have features consistent with the disease as shown by magnetic resonance imaging (MRI)[4].

The same medicinal product as Betaseron®*, Extavia offers patients and physicians a new branded version of interferon beta-1b, a first-line disease-modifying therapy that has been a standard-of-care for MS in the US for more than 16 years[1]. Extavia will be marketed by the Pharmaceuticals Division of Novartis.

"Interferon is a mainstay of treatment in MS," said Doug Jeffery, MD, Associate Professor at Wake Forest University Baptist Medical Center in Winston-Salem, North Carolina, USA. "With the approval of Extavia, patients have another option with a well-established safety and efficacy profile to help manage this disease."

MS is estimated to affect approximately 400,000 patients in the US[2], of whom more than 80% have relapsing-remitting MS[5]. MS is one of the most common causes of neurological disability in young adults. It is a chronic autoimmune disease in which the body's immune system attacks the myelin sheath, or protective tissue surrounding the nerve fibers that carry electrical signals in the brain[6]. The destruction of myelin causes problems with muscle control and strength, vision, balance, sensation and mental function[7].

I'm not listing the references, so if you want to view the entire press release, click here and you will go to the Novartis website.

In case you were wondering:

* Novartis gained the rights to seek approval for its own branded version of interferon beta-1b through agreements with Bayer Schering, the company that markets Betaseron.

Betaseron is marketed under the name of Betaferon® outside the US. Betaseron and Betaferon are registered trademarks of Bayer Schering Pharma AG.

Targeting Angiogenesis in Cancer

Anti-angiogenesis drugs work by blocking the activity of vascular endothelial growth factor (VEGF) to prevent the growth of new capillaries into the tumor and thereby sustain tumor growth. They have significantly changed the landscape of oncology because of their effectiveness and their associated toxicities. There have been several new biologic agents that have been approved and more are coming down the pipeline. Here are a few agents that come to mind:

• Avastin (bevacizumab) is a monoclonal antibody that inhibits angiogenesis and it was approved in 2004. In fact, it was the first agent approved by the FDA to inhibit angiogenesis. Avastin targets vascular endothelial growth factor (VEGF).
• Cediranib (tentative trade name Recentin), also known as AZD2171, is a potent inhibitor of vascular endothelial growth factor (VEGF) receptor tyrosine kinases.
• Vatalanib (PTK/ZK) is a small molecule tyrosine kinase inhibitor with broad specificity that targets all VEGF receptors (VEGFR), the platelet-derived growth factor receptor, and c-KIT.
• Sorafenib (Nexavar) is a multitargeted small molecule that inhibits VEGFR2, FLT3, PDGFR, and fibroblast growth factor receptor-1.
• The list goes on, but I'm going to stop here. This is a blog, not a medical review paper.

So why am I writing about these drugs? I'm curious: do you know who markets these drugs? Everyone probably knows Avastin (Genentech). What about Nexavar (Bayer/Onyx)? How about Recentin (AstraZeneca)? Vatalanib (Bayer Schering/Novartis).

It's exciting to see advances in cancer therapy, but in the spirit of recent healthcare reform discussions, I must ask, "who gets to decide how much (in terms of dollars) therapy a cancer patient should receive?" These biologic agents are very expensive and many patients are having tremendous difficulty paying for them. At what point does it make sense to deny coverage for therapy simply because it's too expensive? Never? I'm glad to I don't work in a managed care organization because these are some of the ethical issues that must get discussed on both an individual and a population level.

What's Happening at the FDA with Rivaroxaban?

Last month, the FDA panel (which included clinical experts) voted 15 to 2 in favor of rivaroxaban (which may get marketed as Xarelto by Bayer and J&J if it receives FDA approval). What's going on at the FDA this month?

Speaking of new anticoagulants, Pradaxa or dabigatran etexilate is another agent that may be nearing approval. This drug is made by Boehringer Ingelheim and has received maketing approval by the European Commission. Unlike rivaroxaban (which is an oral factor Xa inhbitor), dabigatran is an oral direct thrombin inhibitor (DTI). Both are oral pills and both may someday replace warfarin (Coumadin) if they receive FDA approval for anticoagulation.

There's always a bleeding risk associated with an any anticoagulant drug, so the big question is whether the risks outweigh the benefits. Let's hope that these drugs don't follow the same fate as ximelegatran (Exanta).

Rivaroxaban to be Reviewed by the FDA Panel on March 19

March 19 is match day for 4th year medical students. It's also the day when the FDA Panel is supposed to review the anticoagulant rivaroxaban (also known as BAY 59-7939 or Xarelto). It is an oral, direct Factor Xa inhibitor (I don't think I'll ever forget that coagulation cascade diagram that I learned in medical school). If approved, this drug could shut down all those coumadin (warfarin) clinics out there that monitor blood INR in people taking this vitamin K antagonist. Rivaroxaban would not require any blood monitoring. Plus, all those home INR tests manufacturers would need to look for something new to do.

I think everyone is wondering how the FDA will react to this new medication. If approved by the FDA, rivaroxaban will be sold in the US for short-term use as a prophylactic anticoagulant for patients undergoing knee- and hip-replacement surgeries. I'm sure the drug manufacturers will go for additional indications later on. Rivaroxaban is manufactured by Bayer and will be marketed by Ortho-McNeil Pharmaceutical which is a Johnson & Johnson group.