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Perseris Now Obtainable for the Therapy of Schizophrenia in Adults

Posted in News on 20th November 2018

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Advantages of Simplified HCV Therapy Program Investigated

Posted in News on 19th November 2018

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HCV Therapy Linked to Lowered Threat of Incident CVD Occasions

Posted in News on 16th November 2018
Both the incidence rate as well as risk factors for CVD events were assessed

Both the incidence rate as well as risk factors for CVD events were assessed

The risk of incident cardiovascular disease (CVD) events appears to be lower in hepatitis C virus (HCV) infection patients receiving direct-acting antiviral (DAA) regimens compared with those receiving older pegylated interferon-based therapy or no treatment at all, according to a study presented at the Liver Meeting 2018.

ERCHIVES (Electronically Retrieved Cohort of HCV Infected Veterans) was utilized to identify all patients who received HCV treatment for at least 7 weeks as well as a propensity-score matched group who did not receive treatment. Each group included 32,575 patients. Patients with HIV, HBV, or previously diagnosed CVD were excluded from the study. Both the incidence rate (per 1000 person-years) as well as risk factors for CVD events were assessed. 

“The incidence rate for CVD events/1,000 person-years (95% CI) among the treated was 19.10 (17.79, 20.50) vs. 32.37 (30.51, 34.33) among the untreated (P<.01),” the study authors reported. Results of the study also found that patients receiving DAA therapy had a lower risk of incident CVD events compared with those receiving pegylated interferon/ribavirin (HR: 0.68; 95% CI: 0.53, 0.88). Additionally, patients who achieved sustained virologic response (SVR) also had a lower risk of incident CVD events (HR: 0.76; 95% CI: 0.63, 0.92). “Kaplan-Meier curves demonstrated that untreated persons had a shorter CVD event-free survival during 30 months of follow-up compared with the treated persons,” the study authors added.

Results of this study determined that the likelihood of incident CVD events was not only reduced in HCV patients treated with DAA therapy, but also for patients who attained SVR.

As soon as-Every day, Nebulized Bronchodilator Accredited for COPD Therapy

Posted in News on 11th November 2018

November 09, 2018

Yupelri is a long-acting muscarinic antagonist (LAMA)

Yupelri is a long-acting muscarinic antagonist (LAMA)

The Food and Drug Administration (FDA) has approved Yupelri (revefenacin; Theravance and Mylan) inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Yupelri is a long-acting muscarinic antagonist (LAMA); bronchodilation following inhalation of revefenacin is predominantly a site-specific effect. The product is intended for once-daily inhalation by a standard jet nebulizer connected to an air compressor. 

Yupelri was evaluated in 2 dose-ranging trials, 2 replicate 12-week, Phase 3 confirmatory trials, and a 52-week safety trial. In the 2 replicate 12-week, Phase 3 placebo-controlled trials (N=1229), patients aged ≥40 years with moderate to very severe COPD were randomized to receive Yupelri 175mcg once daily or placebo. The primary endpoint was change from baseline in trough FEV1 at day 85. 

Treatment with Yupelri showed significant improvement in lung function vs placebo. In Trial 1, the least square mean change in trough FEV1 was 127mL and -19mL in the Yupelri and placebo groups, respectively (treatment difference 146, 95% CI, 103.7, 188.8). In Trial 2, the least square mean change in trough FEV1 was 102mL and -45mL in the Yupelri and placebo groups, respectively (treatment difference 147, 95% CI, 97.0, 197.1). In addition, the peak FEV1 (within the first 2 hours after dosing) improvement on day 1 vs placebo was 133mL and 129mL in Trials 1 and 2, respectively. 

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In Trial 1, the St. Georges Respiratory Questionnaire (SGRQ) responder rate (defined as an improvement in score of ≥4 as threshold) on day 85 was 49% for the Yupelri arm vs 34% for placebo (odds ratio [OR] 2.11, 95% CI 1.14, 3.92). In Trial 2, the SGRQ responder rate was 45% vs 39%, respectively (OR  1.31, 95% CI, 0.72, 2.38). 

The most common adverse events reported with therapy were cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. 

Yupelri will be available as 175mcg/3mL solution in unit-dose vials packaged in 30-count cartons. 

For more information call (877) 446-3679 or visit Mylan.com.

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First-in-Class Antiviral Permitted for the Remedy of Influenza

Posted in News on 25th October 2018
Xofluza is a first-in-class, single-dose oral medicine with a novel mechanism of action

Xofluza is a first-in-class, single-dose oral medicine with a novel mechanism of action

The Food and Drug Administration (FDA) has approved Xofluza (baloxavir marboxil; Genentech) for the treatment of acute uncomplicated influenza in patients aged ≥12 years old who have been symptomatic for no more than 48 hours.

Xofluza is a first-in-class, single-dose oral medicine with a novel mechanism of action designed to target influenza A and B viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1). Unique to the treatment is its ability to inhibit the cap-dependent endonuclease protein within the flu virus, which is needed for viral replication. “This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” said FDA Commissioner Scott Gottlieb, MD.

The approval was based on 2 randomized controlled trials (N=1832) where study patients were assigned to receive Xofluza, placebo, or oseltamivir within 48 hours of experiencing flu symptoms. The data showed patients who received Xofluza had a shorter time to symptom relief vs patients who received placebo. In the CAPSTONE-1 study, no difference was observed between Xofluza and oseltamivir in the time to alleviation of symptoms. The most common adverse reactions associated with therapy included diarrhea and bronchitis.

According to Genentech, the product is expected to be available in the coming weeks. Xofluza will be supplied as 20mg and 40mg tablets.