2010 in review: We review the last year in terms of the drugs that went bust, and the ones that made it big

Here’s the skinny on the weight loss drugs that disappointed, the hepatitis drugs that matched the hype and others as we look back on the major headlines relating to medications in 2010.

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Green Light

Gilenya (fingolomod)

This drug from Novartis was the first drug for multiple sclerosis in pill form to gain US Food and Drug Administration (FDA) approval. As a sphingosine-1-phosphate modulator, it prevents white blood cells from attacking the nervous system and has proved more effective at reducing relapse rates than interferon-beta, an existing multiple sclerosis drug.

GRNOPC1

Geron’s much-anticipated phase 1 clinical trial of human embryonic stem cell-derived neural precursors for spinal cord injury finally got off the ground when doctors in Atlanta injected these cells, GRNOPC1, into a human subject. The company plans to implant the cells into up to ten people, who will be followed for up to two years, to assess the safety of the treatment.

Tenofovir

A vaginal gel containing this antiretroviral compound reduced the risk of HIV transmission to women by 39% in the CAPRISA 004 clinical trial, which encouraged the FDA to grant fast-track status to the product.


Prolia (denosumab)

This monoclonal antibody developed by Amgen blocks a key molecular promoter of bone removal known as RANKL. It was approved by the FDA in June to treat postmenopausal women with osteoporosis.

Actemra (tocilizumab)

On the basis of positive results from clinical trials involving more than 4,000 people, the FDA approved Actemra—a humanized antibody from Genentech that inhibits the proinflammatory cytokine interleukin-6—for patients with rheumatoid arthritis who have not adequately responded to other approved drugs.

Fostamatinib (R788)

After obtaining promising results from a phase 2 clinical study of fostamatinib in patients with refractory rheumatoid arthritis, AstraZeneca is moving forward with phase 3 clinical trials of the drug, an oral inhibitor of the immune cell signaling molecule spleen tyrosine kinase.

Ipilimumab

This antibody, which is used to enhance the immune response against tumor cells, showed promising results in a phase 3 trial of individuals with metastatic melanoma. Unlike previous therapies, ipilimumab extended survival of previously treated patients with late-stage melanoma, and the FDA has now granted priority review to its biologics license application.

Telaprevir and boceprevir

Current therapy for hepatitis C virus infection cures only a small subset of treated individuals. But recent clinical trials show that these two new drugs—both inhibitors of the viral protease—markedly increase the number of individuals cured of infection and shorten the duration of treatment when combined with the standard-of-care therapy.

Pradaxa (dabigatran)

Approved by the FDA in October 2010, this thrombin inhibitor made by Boehringer Ingelheim is poised to compete with warfarin as another orally available anticoagulant.

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Yellow Light

Avastin (bevacizumab)

The world’s best selling cancer drug, an antibody from Roche’s Genentech unit that blocks the activity of VEGF and inhibits angiogenesis, suffered a setback when an FDA panel recommended rescinding approval for its use in advanced breast cancer.

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