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FDA clears six new drugs in time for the new year

Brings 2012 tally to 39 – the highest for more than 15 years

FDA headquarters

The US FDA added to the tally of new drug approvals in 2012 with six more granted over the holiday period that took its total for the year to 39, the highest for more than 15 years. The latest crop –cleared during the last 10 days of December – is as follows:

Salix Pharmaceuticals won the distinction of becoming only the second company to have a product approved under the FDA's 2004 regulatory route for complex botanical medicines, getting a green light for Fulyzaq (crofelemer) as a treatment for antiretroviral (ARV) therapy associated diarrhoea in people with HIV.

The drug, derived from the red sap of the Croton lechleri plant, tackles a key reason for non-compliance with ARV therapy and is the first treatment approved for this indication in the US. The first botanical approved under the FDA's botanicals regulation was PharmaDerm's genital wart therapy Veregen (sinecatechins).

Janssen Therapeutics - part of the Johnson & Johnson group - secured approval for Sirturo (bedaquiline) as part of a combination therapy for adults with multidrug resistant pulmonary tuberculosis (TB) when other alternatives are not available.

Sirturo is being approved under the FDA's accelerated approval programme on the grounds that it answers a significant unmet medical need, even though it carries a risk of serious and potentially fatal cardiovascular side effects. J&J filed for approval of bedaquiline in Europe last September. The drug is the first with a new mechanism of action for TB in more than 40 years and the only approved treatment for multidrug resistant forms of the disease.

The US regulator gave the go-ahead to Bristol-Myers Squibb and Pfizer's oral anticoagulant Eliquis (apixaban) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation (AF) that is not caused by a heart valve problem.

Eliquis was cleared for the same indication in the EU in November 2012, and is already sold there for preventing venous thromboembolism (VTE) in adult patients who have undergone elective hip or knee replacement surgery.  This is the first approval for the potential blockbuster in the US, and it becomes the third new blood thinner to be approved as an alternative to warfarin in AF after Boehringer Ingelheim's Pradaxa (dabigatran) and J&J/Bayer's Xarelto (rivaroxaban).

Aegerion Pharmaceuticals was granted approval for orphan drug Juxtapid (lomitapide) for a rare cholesterol disorder called homozygous familial hypercholesterolemia (HoFH), which is characterised by an inability to remove harmful low density lipoprotein (LDL) cholesterol from the blood.

HoFH patients tend to suffer heart attacks and deaths, often before the age of 30. Juxtapid is approved for use with a low-fat diet and other therapies to reduce patients' cholesterol levels, with or without LDL apheresis, a dialysis-like procedure in which LDLs are removed from the blood. A similar drug for HoFH from Sanofi/Isis called Kynamro (mipomersen) was turned down by an EU advisory panel in mid-December because of cardiovascular risks, but is still awaiting a verdict from the FDA.

Cangene Corp got the go-ahead for Varizig, its varicella-zoster virus (VZV) immune globulin product for reducing the severity of chickenpox infections in high-risk individuals when given within four days after exposure. It is the only FDA approved immune globulin for VZV after exposure available in the US and has been classed as an orphan drug by the FDA. An earlier immune globulin product called VZIG was removed from the US market by its manufacturer MPHBL Laboratories in 2006.

Finally, the FDA issued an approval for the use of NPS Pharmaceuticals' Gattex (teduglutide) as a treatment for adults with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding.  The drug will compete in the US market with two other SBS treatments, namely EMD Serono's Zorbtive (somatropin) and Emmaus Medical's Nutrestore (glutamine).

2nd January 2013

From: Sales, Regulatory

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