Category Archives: New drugs

FDA approves ATryn (recombinant human antithrombin) for the treatment of hereditary antithrombin deficiency

The FDA issued a press release (February 6th, 2009) announcing the approval of the first biological product produced by genetically engineered animals: recombinant human antithrombin.

Some excerpts from the press release:

The U.S. Food and Drug Administration today issued its first approval for a biological product produced by genetically engineered (GE) animals.

The approval is for ATryn, an anticoagulant used for the prevention of blood clots in patients with a rare disease known as hereditary antithrombin (AT) deficiency.

ATryn is a therapeutic protein derived from the milk of goats that have been genetically engineered by introducing a segment of DNA into their genes (called a recombinant DNA or rDNA construct) with instructions for the goat to produce human antithrombin in its milk. Antithrombin is a protein that naturally occurs in healthy individual and helps to keep blood from clotting in the veins and arteries.

Because hereditary AT deficiency occurs in a small population (approximately 1 in 5,000 people in the United States), the FDA granted ATryn an orphan drug designation. The orphan drug designation system encourages the development of medications for patients with a rare disease or condition.

A diagram explaining the process. Source: NYT

A review of the role of antithrombin in the coagulation cascade:

Rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE): SMC review

The  Scottish Medicines Consortium issued on 7th November, 2008 an advice on rivaroxaban (Xarelto): ADVICE: following a full submissionrivaroxaban (Xarelto®) is accepted for use  within NHS Scotland for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.In three large phase III studies in patients undergoing either total knee…Continue Reading

Atazanavir (Reyataz) for HIV-1 infection: SMC review

The Scottish Medicines Consortium issued on 7th December, 2008 an advice on the recently approved protease inhibitor Atazanavir (Reyataz) Atazanavir (Reyataz) is accepted for use within NHS Scotland in antiretroviral treatment naïve HIV-1 infected adults in combination with other antiretroviral medicinal products. The combination of atazanavir and ritonavir was non-inferior to a standard boosted protease inhibitor…Continue Reading

Nilotinib (Tasigna) for chonic myeloid leukemia: Health Canada evaluation

Information from Health Canada issued October 14, 2008 about the recently approval of nilotinib (Tasugna) On September 9, 2008, Health Canada issued a Notice of Compliance under the Notice of Compliance with Conditions (NOC/c) Policy to Novartis Pharmaceuticals Canada Inc. for the drug product Tasigna*. The product was authorized under the NOC/c Policy on the…Continue Reading

Methylnaltrexone (Relistor) for opioid induced constipation: SMC review

The Scottish Medicines Consortium issued on 8th December, 2008 an advice on the recently approved opioid antagonist methylnaltrexone ADVICE: following a full submissionMethylnaltrexone  (Relistor)  is  accepted  for  restricted  use  within  NHS  Scotland  for treatment  of  opioid-induced  constipation  in  advanced  illness  patients  who  are  receiving palliative care when response to usual laxative therapy has not been…Continue Reading

Varenicline (Champix) psychiatric adverse effects: recommendations to patients from Health Canada

Health Canada has issued  an information update about varenicline (Champix), giving some recommendations to patients: Information Update 2009-01 January 6, 2009 For immediate release OTTAWA – Health Canada is reminding Canadians who are taking, or considering taking, the smoking-cessation aid Champix of important safety information for this product. Health Canada is also informing Canadians that…Continue Reading

Febuxostat (Adenuric, Ipsen) for the management of hyperuricemia in gout patients. NICE guidance

The following is an excerpt of the NICE guidance about: Febuxostat for the management of hyperuricaemia in people with gout. 1 Guidance 1.1 Febuxostat, within its marketing authorisation, is recommended as an option for the management of chronic hyperuricaemia in gout only for people who are intolerant of allopurinol (as defined in section 1.2) or…Continue Reading

Review of nepafenac (Nevanac) ophtalmic suspension

Review form Health Canada of nepafenac (Nevanac) , a non-steroidal anti-inflammatory drug (NSAID) for the management of pain and inflammation associated with cataract surgery On April 17, 2008, Health Canada issued a Notice of Compliance to Alcon Canada Inc. for the drug product, NevanacTM (nepafenac) Ophthalmic Suspension. NevanacTM contains the medicinal ingredient nepafenac which is…Continue Reading

Etravirine (Intelence) review from Health Canada

Information about: etravirine (Intelence) for the treatment of HIV-1 infection in treatment-experienced adult patients who have failed prior therapy and have HIV-1 strains resistant to multiple antiretroviral agents, including NNRTIs. From Health Canada. On March 27, 2008, Health Canada issued a Notice of Compliance to Janssen-Ortho Inc. for the drug product Intelence.Continue Reading

Dabigatran (Pradaxa, Pradax) for the prevention of VTE. Mechanism of action, indications, contraindications, pharmacodynamics and pharmacokinetics.

Information about dabigatran (Pradaxa in Europe, Pradax in Canada) for the prevention of venous thromboembolic events (VTE), from Health Canada. On June 10, 2008, Health Canada issued a Notice of Compliance to Boehringer Ingelheim Canada Ltd. for the drug product, Pradax. Pradax contains the medicinal ingredient dabigatran etexilate used in its salt form, dabigatran etexilate…Continue Reading

Sitaxentan (Thelin) for pulmonary hypertension. Australian Prescriber review

From Australian Prescriber: Sitaxentan sodium Thelin (CSL) 100 mg tablets Approved indication: pulmonary hypertension Australian Medicines Handbook section 6.7.2 Pulmonary hypertension results from intimal hypertrophy narrowing small pulmonary arteries. The increase in pulmonary vascular resistance leads to right ventricular failure. Primary pulmonary hypertension is less common than the pulmonary hypertension associated with other conditions such…Continue Reading

Degarelix (Firmagon) for prostate cancer: now approved by FDA

Related to EMEA’s positive opinion on degarelix (Firmagon) for prostate cancer, FDA issues this press release dated Dec. 29, 2008: FDA Approves Drug for Patients with Advanced Prostate Cancer The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer.  Continue Reading

Duloxetine (Cymbalta, Yentreve): a serotonin-norepinephrine reuptake inhibitor for major depression. Australian prescriber review

From Australian Prescriber: Duloxetine Cymbalta (Eli Lilly) 30 mg and 60 mg capsules Approved indication: major depression Australian Medicines Handbook section 18.1.2 Duloxetine is a new antidepressant which selectively inhibits serotonin and noradrenaline reuptake. It also weakly inhibits dopamine uptake. (See details of its mechanism of action)Continue Reading

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