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Weekly Drug News Round Up - July 17, 2013

Gilotrif Approved for Lung Cancer After FDA Priority Review

Roughly 200,000 Americans will be diagnosed with lung cancer this year, and close to 70 percent will die from the disease Read More...

Gilotrif (afatinib), a kinase inhibitor indicated for the treatment of patients with late-stage (metastatic) non-small cell lung cancer (NSCLC), has been FDA-approved after a priority review. Gilotrif is approved for patients whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. In Boehringer Ingelheim’s Gilotrif clinical trial, patients receiving Gilotrif had a delay in tumor growth (progression-free survival) that was 4.2 months longer than those receiving the chemotherapy drugs pemetrexed and cisplatin -- there was no difference in overall survival time. This past May, the FDA also approved Tarceva (erlotinib) for first-line treatment of patients with NSCLC.

Khedezla Approved for Major Depressive Disorder

Khedezla will be available in 50 mg and 100 mg strength tablets for once daily administration Read More...

The U.S. Food and Drug Administration (FDA) has approved Osmotica Pharm’s Khedezla (desvenlafaxine) for major depressive disorder (MDD). Khedezla contains extended-release desvenlafaxine base, a serotonin and norepinephrine reuptake inhibitor (SNRI). Pristiq was approved by the FDA in 2008 for the same indication and contains desvenlafaxine as the succinate salt. Generic forms of the succinate salt, covered by a Pfizer patent, will not be available until 2022. Alembic Pharm’s generic desvenlafaxine base was also FDA-approved in March for MDD; Ranbaxy now markets that drug.

Link Found Between Diabetes Drug Metformin and Lower Risk of Dementia

It is proposed that metformin may play a role in the development of new brain cells (neurogenesis) Read More...

A new study suggests an inexpensive oral diabetes drug may also help ward off memory-robbing dementia. Researchers from Kaiser Permanente reviewed data on nearly 15,000 people with type 2 diabetes who were just starting single-drug therapy for their disease. Compared to people taking another type of diabetes medications called sulfonylureas, those taking metformin had a 20 percent reduced risk of developing dementia over the five-year study period. However, the study was observational, retrospective and population-based, which means it does not prove cause and effect. Further research is ongoing.

Roche Halts Development of Diabetes Drug Due to Serious Side Effects

The aleglitazar studies were scheduled to last until the beginning of 2015 Read More...

The pharmaceutical manufacturer Roche has stopped late-stage research on aleglitazar, an investigational type 2 diabetes drug being developed to also lower heart attack and stroke risks. During clinical trials, it was found that aleglitazar increased risks for sides effects such as bone fractures, kidney impairment, and heart failure. Aleglitazar is a thiazolidinedione and in the same class of drugs as Avandia (rosiglitazone), a restricted access drug which has been under recent fire due to the possibility of heart attacks and stroke. An FDA advisory committee recently recommended to the FDA that the tight restrictions on Avandia be eased; FDA is still considering these recommendations.

New Combinations of Existing Drugs Help to Combat Resistant Gonorrhea

Untreated, gonorrhea can lead to problems with the prostate and testicles for men, and infertility in women Read More...

Gonorrhea is a common sexually transmitted disease in the U.S., with more than 800,000 new infections occurring each year. Drug-resistant bacteria have been a concern, but two new antibiotic regimens use existing drugs in combinations -- injectable gentamicin with azithromycin, or oral gemifloxacin with azithromycin. Both regimens were shown to be close to 100 percent effective, but with unpleasant stomach side effects. These findings do not change the current first-line gonorrhea treatment guidelines -- injectable ceftriaxone, in combination with either azithromycin or doxycycline. This guideline therapy is highly effective in treating gonorrhea and causes limited side effects.