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Weekly Drug News Round Up - December 24, 2014

Opdivo Wins Accelerated Approval for Advanced Melanoma

Bristol-Myers Squibb's Opdivo (nivolumab) is the seventh new melanoma drug approved by the FDA since 2011 Read More...

Over 9,700 Americans will die from advanced melanoma in 2014. To combat this life-threatening condition, the U.S. Food and Drug Administration has approved Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor for patients with advanced melanoma or melanoma that cannot be removed surgically and who no longer respond to other drugs. In studies, 32% of participants receiving Opdivo had their tumors shrink with the effect lasting for more than six months in approximately one-third of this group. Side effects include rash, itching, cough, upper respiratory tract infections, and fluid retention; severe immune-mediated side effects involving healthy organs may occur, as well.

BioCryst's Rapivab FDA-Approved for Influenza

Antiviral drugs used to treat flu are not substitutes for early, annual flu vaccination Read More…

The U.S. Food and Drug Administration has approved intravenous (IV) Rapivab (peramivir) to treat influenza infection in adults. Rapivab is the first IV neuraminidase inhibitor approved to treat the flu and is given as a single dose. In trials, those receiving Rapivab 600 mg had their symptoms alleviated an average of 21 hours sooner than the placebo group, and temperature returned to normal roughly 12 hours sooner. The most common side effect was diarrhea; rare, but serious allergic skin reactions can occur, too. Other commonly used neuraminidase inhibitors include Relenza (zanamivir), which is inhaled, and Tamiflu (oseltamivir) given orally.

FDA Gives Lynparza Accelerated Approval

Lynparza is the first of a new class of drugs for treating ovarian cancer Read More...

Ovarian cancer forms in the ovary, a female reproductive gland where ova, or eggs, are formed. In 2014, roughly 14,000 American women will die from ovarian cancer. Last week the U.S. Food and Drug Administration (FDA) granted accelerated approval to Lynparza (olaparib) capsules, a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test. Lynparza belongs to a new class of drugs called poly ADP-ribose polymerase (PARP) inhibitors. Lynparza is for women who have already received extensive treatment for advanced ovarian cancer associated with defective BRCA genes.

AbbVie’s Viekira Pak Wins HCV Approval

Most people infected with HCV have no disease symptoms until liver damage becomes apparent, which may take decades Read More...

The U.S. Food and Drug Administration (FDA) has approved Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection. Viekira Pak contains three new drugs - ombitasvir, paritaprevir and dasabuvir - that inhibit the growth of HCV. It also contains ritonavir used to increase paritaprevir blood levels. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis). For HCV treatment, the FDA also approved Olysio (simeprevir), Sovaldi (sofosbuvir), and Harvoni (ledipasvir and sofosbuvir) in 2014.

Zerbaxa Approved as Fourth New Antibacterial in 2014

Zerbaxa is first antibiotic approved under the Generating Antibiotic Incentives Now (GAIN) Act to treat Gram-negative bacteria Read More...

Cubist’s Zerbaxa contains ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor. Zerbaxa was FDA-approved last week to treat complicated intra-abdominal infections in combination with metronidazole and complicated urinary tract infections, including kidney infection (pyelonephritis). The approval of Zerbaxa was supported by positive data from two pivotal Phase 3 clinical trials. The agency also approved the antibacterials Dalvance (dalbavancin) in May, Sivextro (tedizolid) in June and Orbactiv (oritavancin) in August.