|FDA Approves Prescribing Eli Lilly's Tradjenta; Idenix Shares Drop After Hepatitis Drug Study Put on Hold|
|By Staff and Wire Reports|
|Friday, 17 August 2012 18:34|
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company(NYSE: LLY) announced the U.S. FDA has approved a supplemental new drug application (sNDA) for Tradjenta® (linagliptin) tablets for use as add-on therapy to insulin. TRADJENTA is a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes, such as metformin, sulfonylurea, pioglitazone or insulin. TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).
The FDA's decision is based on data from a 52-week, phase 3 trial demonstrating the efficacy of TRADJENTA in combination with insulin (with or without metformin and/or pioglitazone). The trial results showed adding TRADJENTA to insulin produced better glucose control than insulin alone, with similar incidence of hypoglycemia (low blood sugar) in both treatment groups.1 TRADJENTA belongs to a class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors and is the first member of its class to be approved at one dosage strength (5 mg, once-daily).
Additionally, the FDA-approved label includes a clinical study in people with severe chronic renal impairment. Data from a 52-week, double-blind, randomized, placebo-controlled trial showed that use of TRADJENTA 5 mg plus other glucose-lowering therapies in this patient population provided a statistically significant improvement in glycated hemoglobin (HbA1c or A1C) compared to placebo (placebo-adjusted reduction of 0.7 percent).
Idenix Pharmaceuticals (NASDAQ: IDIX) shares tanked after the company said the FDA was putting a partial hold on human studies of the company's experimental hepatitis C treatment.
The FDA is concerned about potential heart risk in patients after a safety issue was discovered in a similar drug being developed by Bristol-Myers Squibb (NYSE: BMY). Initially, Bristol-Myers' setback -- which led to the suspending of its drug trial -- seemed to be a positive for Idenix and other companies in the race for a better hepatitis treatment.
Idenix CEO Ronald Renaud told investors on a conference call Thursday that the company hasn't seen any evidence in studies so far that would suggest its drug, known as IDX184, poses a serious heart threat. The company will provide additional study data to the FDA as it tries to show that the drug is safe.
“We remain confident in the safety profile” of the drug, Renaud said on the call.
Evidence of heart failure is the type of risk that can kill an experimental drug even if there are only one or two cases among 10,000 patients, Leerink Swann analyst Howard Liang says in a recent note.
So far, the other leading companies developing similar hepatitis C drugs, including Gilead Sciences (NASDAQ: GILD) and Vertex Pharmaceuticals (NASDAQ: VRTX) have not indicated there are any heart safety issues related to their medicines.
Idenix, Gilead, Vertex, and Bristol-Myers have all been studying a class of drugs known as nucleotide polymerase inhibitors. The drugs target an enzyme needed for the hepatitis C virus to replicate. The goal of all these companies is to create an all-oral regimen for hepatitis patients that doesn't include the injected therapy interferon, which can cause side effects such as fatigue and flu-like symptoms.
The government estimates as many as 3.9 million people in the US may be chronically infected with the liver-destroying virus. Worldwide, that figure is about 150 million, according to the World Health Organization.
ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology and oncology supportive care, will host an investor call to update investors on MuGard commercialization activities, including progress with pharmacy benefit managers, payers and pharmacy formularies, and other new developments within the program.
China Cord Blood Corporation (NYSE: CO) ("the Company") today announced its plan to release financial results for the first quarter of fiscal year 2013 on Wednesday, August 22, 2012, after market close in the US.
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pioglitazone Tablets USP, 15 mg, 30 mg and 45 mg.