The FDA has approved a once-a-month buprenorphine injection for the treatment of opioid use disorder. The injection is approved for adult patients with moderate-to-severe opioid use disorder and who have initiated treatment with a buprenorphine-containing product and are on a stable dose for at least one week. It is injected subcutaneously by a healthcare professional as part of a comprehensive approach. Safety and efficacy were evaluated in two studies, including one randomized, controlled trial of 848 adults with opioid use disorder, which showed that treated patients experienced more weeks without positive urine tests or self-reports of opioid use. Additionally, a higher proportion of patients demonstrated no evidence of illicit opioid use throughout the treatment period compared to the placebo group. Buprenorphine injection was granted priority review and fast-track designation. It is marketed as Sublocade.
The FDA has approved evolocumab (Repatha) to prevent cardiovascular events. The PCSK9 inhibitor previously was approved for familial hypercholesterolemia or adjunct treatment of atherosclerotic cardiovascular disease. The new indication was based on results from the FOURIER trial in which more than 27,000 patients with atherosclerotic cardiovascular disease on statins were randomized to receive evolocumab injections every two weeks or a matching placebo. After a little more than two years of follow-up, evolocumab reduced the absolute risk of cardiovascular disease by 1.5% (9.8% vs. 11.3%; hazard ratio, 0.85; 95% CI, 0.79-0.92; P < 0.001) (doi: 10.1056/NEJMoa1615664). Repatha has been slow to gain traction in the United States, in part because of its price tag: more than $14,000 per year.
The FDA has approved the eighth biosimilar in the United States: trastuzumab-dkst as a biosimilar to trastuzumab (Herceptin). The drug is approved for the treatment of patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 gene (HER2+). It represents the second biosimilar approved for the treatment of cancer, after bevacizumab-awwb (biosimilar to bevacizumab/Avastin). Approval of trastuzumab-dkst was based on extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data, which demonstrated that trastuzumab-dkst is biosimilar to trastuzumab. While the new product features the same indications as the originator drug, they are not considered interchangeable. Trastuzumab-dkst carries the same warnings, including boxed warnings, as trastuzumab. Trastuzumab-dkst is marketed as Ogivri.
The FDA has approved the first two-drug regimen for the treatment of HIV in certain adults. Previously, standard HIV treatment included three or more drugs. The new fixed-dose tablet contains two previously approved drugs: dolutegravir and rilpivirine. It is approved for adults with HIV-1 whose virus currently is suppressed on a stable regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to either dolutegravir or rilpivirine. Safety and efficacy of the two-drug regimen were evaluated in two clinical trials that contained more than 1,000 stable patients who were randomized to continue their current therapy or change to dolutegravir/rilpivirine. The results showed that the new two-drug combination was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV drugs. Dolutegravir/rilpivirine is marketed as Juluca.
In this section: FDA approves treatment for opioid use disorder, greenlights product to reduce cardiovascular events, gives the go-ahead to the eighth biosimilar, and approves a two-drug HIV regimen.
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