FDA approves supplemental NDA for Januvia
WASHINGTON The FDA approved a supplemental new drug application for Merck’s Type 2 diabetes drug Januvia, citing new uses and additional warnings.
The pharmaceutical company, which produces several heart-related medications, had received feedback from patients taking Januvia (sitagliptin) experiencing health problems including anaphylaxis, angioedema and undesirable skin conditions. There had been reports that patients experienced the potentially fatal skin condition known as Stevens-Johnson Syndrome.
Januvia’s revised labeling will now indicate that patients with a history of hypertension should not use the drug. The company said, however, it could not establish a causal relationship to the drug or reliably estimate the frequency of the side effects.
The updated labeling additionally states that Januvia can be used as an initial therapy or add-on therapy with other medications, including metformin and sulfonylurea.
GSK ready to cut jobs following quarterly losses
PHILADELPHIA GlaxoSmithKline is ready to let some of its workers go to make up for its recent report of lost earnings.
The company reported that total pharmaceutical turnover for the third quarter fell by 2% to $9.4 billion. In the United States, turnover fell 7% to $4.5 billion, impacted by continued generic competition and largely because of a 38 percent drop in sales of its diabetes drug Avandia.
The plan is a three-year $1.4 billion move that includes job cuts, most likely starting at its Avandia sales force. According to the London Times, the company is awaiting what the Food and Drug Administration will report about their findings on Avandia and if it should receive a “black box” warning for heart attack risks.
FDA approves Marillion NDA for novel cancer treatment
MALVERN, Pa. Marillion Pharmaceuticals has received approval from the Food and Drug Administration for it investigational new drug application for its lead product candidate MN-201, a vitamin D5 analog for the treatment of cancer.
The drug will now proceed to Phase 1 human clinical trial for patients with advanced tumors in various cancers.
In preclinical studies, MN-201 performed well against cancer cells. In animal models, MN-201 also resulted in anti-tumor activity including tumor regression in xenograft models of major solid tumor types. In contrast to treatment with other vitamin D(3) analogs and the naturally occurring vitamin D hormone, calcitriol, favorable anticancer effects with MN-201 were observed in the absence of significantly raised calcium levels.