New biologic: Alpha-1-proteinase inhibitor (human) for injection (Glassia) was approved for the treatment of chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor.
Alpha-1-proteinase inhibitor (human) for injection is indicated for the treatment of chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor (also commonly referred to as alpha-1-antitrypsin (AAT) deficiency). AAT deficiency is a chronic, autosomal, co-dominant hereditary disorder characterized by reduced levels of alpha-1-proteinase inhibitor in the blood and lungs. Alpha-1-proteinase inhibitor (human) is prepared from human plasma obtained from US-licensed plasma collection centers.
Efficacy. A phase 2/3 randomized, double blind, active controlled trial was conducted to compare intravenous Glassia to Prolastin (another FDA-approved alpha-1-proteinase inhibitor) in AAT-deficient patients. Patients were required to have lung disease related to alpha-1-proteinase inhibitor deficiency and "at-risk" alleles associated with alpha-1-proteinase inhibitor plasma levels <11 μM. Subjects already receiving alpha-1-proteinase inhibitor therapy were required to undergo a 5-week wash-out period. Patients were randomly assigned to receive either Glassia (n=33 patients) or Prolastin (n=17 patients) at a dose of 60 mg/kg intravenously per week for 12 consecutive weeks. From week 13 to 24, all subjects received open-label weekly infusions of Glassia at a dose of 60 mg/kg. Trough levels of functional and antigenic alpha-1-proteinase inhibitor were measured prior to treatment, at baseline, and throughout the study until week 24. Glassia was shown to be non-inferior to Prolastin. Furthermore, all subjects receiving Glassia had mean serum trough antigenic alpha-1-proteinase inhibitor levels >11 μM (levels above this are thought to be protective) during weeks 7 to 12. It is important to note; however, the clinical efficacy of Glassia in influencing the course of pulmonary emphysema or the frequency, duration, or severity of pulmonary exacerbations has not been demonstrated in a randomized, controlled clinical trial setting.
Safety. A total of 68 patients have received treatment with Glassia as part of 2 US-based clinical studies. The most common Glassia-related adverse reactions-occurring in >3% of patients in clinical studies-were headache (6%) and dizziness (3%). Since Glassia is derived from human plasma, its use may carry a risk of transmitting infectious agents (theoretically including the Creutzfeldt-Jakob disease agent) despite manufacturing steps designed to minimize the risk of viral transmission.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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