Regulatory Focus™ > News Articles > 2020 > 7 > FDA Approvals Roundup: Rukobia, Byfavo, Inqovi

FDA Approvals Roundup: Rukobia, Byfavo, Inqovi

Posted 08 July 2020 | By Renee Matthews 

FDA Approvals Roundup: Rukobia, Byfavo, Inqovi

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals
Rukobia gets the green light for hard-to-treat HIV
ViiV Healthcare’s Rukobia (fostemsavir) has been approved for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant infection whose current antiretroviral regimen is ineffective because of resistance, intolerance, or safety concerns.
The drug, a first-in-class HIV-1 gp120-directed attachment inhibitor, is taken as an extended release tablet twice daily in combination with other antiretrovirals.
FDA granted the application fast track, breakthrough therapy, and priority review designations.
The drug’s safety and efficacy were evaluated in the phase 3, partially randomized, placebo-controlled BRIGHTE study in 371 heavily treatment-experienced adult participants with persistently high levels of virus (HIV-RNA) despite receiving antiretroviral treatment. In all, 71% of participants had been treated for HIV for more than 15 years, 85% had received five or more different HIV treatments before joining the trial, and/or 86% had a history of AIDS.
Of the 371 participants, 272 were randomized to receive either Rukobia or placebo twice daily, together with their failing antiretroviral regimen. The remaining 99 participants were in a nonrandomized cohort of the study. They had no fully active antiretroviral agents at screening and received Rukobia plus an investigator-selected optimized background therapy (OBT).
By day 8 of the trial, participants treated with Rukobia had a significantly greater decrease in their levels of HIV-RNA compared with those receiving placebo. After the eighth day, all participants received Rukobia with an OBT. After 24 weeks of Rukobia, along with other antiretroviral drugs, 53% of participants achieved HIV RNA suppression to levels of HIV low enough to be considered undetectable. At the 96-week mark, 60% of participants had continued HIV RNA suppression.
Byfavo okayed for sedation during short-duration procedures
Cosmo Pharmaceuticals’/Acacia Pharma’s Byfavo (remimazolam injection) has been approved for the induction and maintenance of sedation in adults undergoing short-duration medical procedures. 
The very rapid onset/offset IV benzodiazepine sedative is used during invasive procedures, such as colonoscopy and bronchoscopy, that last about 30 minutes or less. The drug will not be marketed in the US until the Drug Enforcement Administration has determined its scheduling under the Controlled Substances Act, which is expected to take place within the next few months.
“The approval of [Byfavo] is very exciting for proceduralists, as the field has not seen new sedation medications added to our armamentarium in decades,” said Gerard A. Silvestri, MD, MS, professor of medicine at the Medical University of South Carolina, Charleston.
The drug’s safety was evaluated in three studies in 969 patients undergoing colonoscopy (two studies) or bronchoscopy (one study), of whom 630 received Byfavo. The most common adverse reactions after administration of the sedative were hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension.
The Byfavo labeling includes a boxed warning about appropriate training of personnel and equipment that should be available during administration,  sedation, the recovery period of the procedure. The warning also addresses risks related to concomitant use with opioid analgesics and other sedative hypnotics.
Inqovi approved as tablet combo for at-home use for MDS
Astex’s Inqovi (decitabine and cedazuridine) has been approved in tablet form for adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).
“The FDA remains committed to providing additional treatments to patients during the coronavirus pandemic. In this case, the FDA is making available an oral outpatient treatment option that can reduce the need for frequent visits to health care facilities,” said Richard Pazdur, MD, director of the agency’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the agency’s Center for Drug Evaluation and Research.
FDA granted the application priority review, which also used the Oncology Center of Excellence Assessment Aid and the Office of Pharmaceutical Quality’s Assessment Aid for quality review to facilitate the assessment. The agency collaborated with its international agency counterparts in Project Orbis on the review of this application.
The approval was based on clinical trial results showing similar drug concentrations between intravenous decitabine and Inqovi. About half of the patients who were formerly dependent on transfusions did not require transfusions during an 8-week period. The safety profiles of Inqovi and intravenous decitabine were similar.
Decitabine is a nucleoside metabolic inhibitor that was originally approved in 2006 as Dacogen for treatment of patients with MDS. Cedazuridine, a cytidine deaminase inhibitor, has not been previously approved.
Hulio joins line-up of approved Humira biosimilars on hold until 2023  
Mylan’s Hulio (adalimumab-fkjp injection), a biosimilar to AbbVie’s Humira (adalimumab), has received FDA approval, but it will have to wait until 2023 before it can enter the US market because of 2018 patent agreements with AbbVie.
The immunosuppressive tumor necrosis factor blocker in indicated for the treatment of juvenile idiopathic arthritis in patients aged 4 years or older; adult Crohn’s disease; and rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis, all in adults. The product comes with a boxed warning for serious infections and malignancy risk.
According to a press release from AbbVie in 2018, it will grant Mylan a nonexclusive license, effective 31 July 2023, to AbbVie's intellectual property relating to Humira in the United States and other countries where AbbVie has intellectual property, excluding Europe. Mylan will pay royalties to AbbVie for licensing its Humira patents once Hulio has been launched.
AbbVie also has a global resolution with Amgen (Amjevita, adalimumab-atto) to enter the US market on 31 January 2023, and a similar resolution with Samsung Bioepis (Hadlima, adalimumab-bwwd) to enter the US market on 30 June 2023.


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