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Weekly Drug News Round Up - February 4, 2015

Accelerated Approval Granted to Pfizer’s Ibrance

Analysts forecast Ibrance sales at roughly $3 billion a year by 2020; the FDA decision came almost 2 months early Read More...

Pharma giant Pfizer received a new drug approval this week with palbociclib (Ibrance), which is touted as having mega-blockbuster potential. Palbociclib is a CDK4/6 inhibitor for breast cancer, used with letrozole, and received FDA priority review designation in October 2014. It also received breakthrough drug status. Ibrance is used in treatment naive postmenopausal women with metastatic ER+, HER2-breast cancer. In clinical trials, participants treated with Ibrance plus letrozole lived about 20.2 months without their disease progressing (progression-free survival), compared to about 10.2 months seen in those receiving only letrozole. Information on overall survival is not yet available.

Alcon’s Pazeo Approved for Itchy Eyes

Roughly 20% of the U.S. population struggles with seasonal eye allergies Read More...

Pazeo (olopatadine hydrochloride) is a mast cell stabilizer for the treatment of ocular itching associated with allergic conjunctivitis (eye allergies). This week, the U.S. Food and Drug Administration (FDA) gave a thumb’s up to Alcon’s Pazeo ophthalmic solution 0.7%, a once-daily eye drop. In clinical trials, Pazeo demonstrated statistically significantly improved relief of ocular itching associated with allergic conjunctivitis at 24 hours post-treatment compared to olopatadine 0.2% (Pataday).The most common side effects with either Pazeo or the vehicle were blurred vision, dry eye, keratitis, abnormal taste and abnormal sensation in the eye.

Glyxambi From Lilly and BI Now Approved for Type 2 Diabetes

Glyxambi should not be used in patients with severe renal impairment, end-stage renal disease, or on dialysis Read More...

The U.S. Food and Drug Administration (FDA) has approved Glyxambi (empagliflozin and linagliptin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D). Glyxambi has a dual mechanism of action, and is the first diabetes treatment in the U.S. to combine a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor in a once-daily tablet. These agents work together by blocking kidney glucose (sugar) uptake, by boosting insulin production, and by lowering liver glucose production. In Phase III trials, Glyxambi showed statistically significant reductions in A1C compared with empagliflozin and linagliptin alone at 24 weeks.

BMS’s Dual Agent Evotaz Cleared for HIV-1 Infection Treatment

In the study, zero protease inhibitor resistance was detected through 48 weeks Read More...

Evotaz (atazanavir 300 mg and cobicistat 150 mg) is a combination, once-daily tablet approved this past week for the treatment of HIV-1 infection in adults. Evotaz combines the protease inhibitor atazanavir (Reyataz) and cobicistat (Tybost), a pharmacokinetic enhancer. In clinical trials at 48 weeks, 85% of patients in the Evotaz arm achieved HIV-1 RNA levels of <50 copies/mL compared to 87% of patients in the Reyataz/ritonavir arm. Low rates of virologic failure (HIV-1 RNA ≥50 copies/mL: 6% Evotaz arm; 4% Reyataz/ritonavir arm) were observed at 48 weeks. Gilead also has an HIV-1 agent called Stribild that combines cobicistat with elvitegravir, emtricitabine and tenofovir.

Prezcobix: Janssen’s Combo HIV-1 Infection Pill Wins Approval

About 50,000 Americans are diagnosed with HIV every year, a number that has held steady since the mid-1990s Read More...

Prezcobix has been FDA-approved for the treatment of HIV-1 (Human Immunodeficiency Virus 1) in adults. Prezcobix contains 800 mg of the protease inhibitor darunavir (Prezista) and 150 mg of the pharmacokinetic enhancer cobicistat (Tybost). This new agent is used in combination with other antiretroviral medicines to treat HIV-1 infection. Prezcobix is used in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated substitutions; genotypic testing is recommended prior to initiation of therapy. The dose is one tablet daily with food. Prezcobix joins Evotaz as the first approved protease inhibitor and cobicistat fixed-dose combinations.