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Weekly Drug News Round Up - May 2, 2012

Elelyso Approved for Rare Type 1 Gaucher Disease

Elelyso (taliglucerase alfa) injection okayed as an orphan drug to replace missing enzyme in rare genetic disorder Read More...

Type 1 Gaucher disease occurs in roughly 6,000 people in the U.S. Patients with type 1 Gaucher disease produce low levels of the glucocerebrosidase enzyme needed for lipid and carbohydrate metabolism. Low enzyme levels result in liver, kidney and spleen damage due to fat accumulation, as well as anemia and bone lesions. Elelyso (taliglucerase alfa) injection has been approved as the first plant cell-based enzyme replacement therapy (ERT) for Gaucher disese. Clinical trials documented the effectiveness of Elelyso at doses ranging from 11 to 73 units per kilogram via intravenous infusion every two weeks. Other ERTs approved for Gaucher disease in the U.S. include imiglucerase (Cerezyme) and velaglucerase (Vpriv).

Stendra: Another Option for Erectile Dysfunction is Approved

Additional PDE5 inhibitor is approved, but unique benefits not apparent Read More...

Joining the ranks of Viagra (silenafil), Cialis (tadalafil), and Levitra (vardenafil), another phosphodiesterase type 5 (PDE5)  inhibitor for erectile dysfunction (ED) by the brand name of Stendra (avanafil) has been approved by the U.S. Food and Drug Administration. It is not clear if there are advantages to Stendra over the currently marketed ED products, although it does have a rapid onset of action, and is taken only 30 minutes prior to sexual activity. Cardiovascular warnings similar to the other available ED products are included on the Stendra label. Stendra should not be used in men who take nitrates for angina (chest pain) due to the possibility for severe hypotension (lowered blood pressure).

Votrient Receives Orphan Drug Status for Rare Soft Tissue Cancer

Votrient offers an option to possibly extend progression-free survival for soft tissue sarcoma patients Read More...

Votrient (pazopanib), already indicated for treatment of advanced renal cell carcinoma (kidney cancer), has been approved as an orphan drug for treatment of advanced soft tissue sarcoma. Soft tissue sarcoma is a rare cancer occurring in roughly 10,000 patients per year in the U.S. It begins in various tissues, including the muscle, fat, or fibrous tissues. Votrient approval was based on a single, placebo-controlled clinical trial in 369 patients who had previously received chemotherapy. Votrient extended progression-free survival for a median of 4.6 months compared to 1.6 months for the placebo group. Votrient side effects included diarrhea, high blood pressure, and hair color changes, among others.

Afinitor Indications Extended to Treat Non-Cancerous Kidney Tumors

Renal angiomyolipomas (kidney tumors) now have a medical treatment in addition to surgical options Read More...

Afinitor (everolimus) has received accelerated approval as the first medical treatment for renal angiomyolipomas (benign kidney tumors) in patients with tuberous sclerosis complex (TSC). TSC is a genetic disorder that results in non-cancerous tumor formation in vital organs, such as the kidney and the brain. Roughly 80% of TSC patients will form renal angiomyolipomas. Afinitor approval was based on the placebo-controlled, Phase III EXIST-2 trial that demonstrated a statistically significant 42% response in the Afinitor group compared to a 0% response rate for the placebo group. Statistically positive results were also seen in angiomyolipoma and skin lesion progression. Common Afinitor side effects include stomatitis, upper respiratory tract infections, and fever.

FDA: Drug Interactions Between Victrelis and Certain Protease Inhibitors

Drug interactions between protease inhibitor Victrelis and certain HIV drugs may lower effectiveness of both drugs Read More...

Healthcare providers should note that the Victrelis (boceprevir) label is now updated to reflect a drug interaction with certain HIV drugs. Victrelis is a protease inhibitor that is used together with other medications for treatment of chronic hepatitis C virus (HCV). A drug interaction study has shown that taking Victrelis with ritonavir-boosted HIV protease inhibitors Reyataz (atazanavir), Prezista (darunavir), or the combination agent Kaletra (lopinavir/ritonavir) may reduce blood levels and effectiveness of both the HIV medications and Victrelis. Healthcare providers who have patients on Victrelis and a ritonavir-boosted protease inhibitor should monitor them for lowered HCV treatment response and for HCV or HIV virologic rebound. Patients on these medications should not stop or adjust their medication regimen without first contacting their healthcare provider.