August 10, 2020

New IV Opioid Approved for Use in Controlled Settings

MONDAY, Aug. 10, 2020 -- The opioid Olinvyk (oliceridine) was granted approval for the management of moderate-to-severe acute pain in controlled settings, the U.S. Food and Drug Administration announced Friday.

Olinvyk is indicated for short-term intravenous use in adults with pain that is severe enough to require an intravenous opioid and who are inadequately treated with other alternatives. The drug is approved only for use in hospitals or other controlled settings and is not for at-home use. The maximum recommended daily dose is 27 mg.

August 10, 2020

FDA Approves First Oral Drug for Spinal Muscular Atrophy

MONDAY, Aug. 10, 2020 -- The U.S. Food and Drug Administration has approved the first oral, at-home drug for spinal muscular atrophy (SMA), the agency announced Friday.

Evrysdi (risdiplam) was approved to treat patients ages 2 months and older with SMA and is the second drug approved for the disease. The drug is administered daily at home by mouth or feeding tube.

July 27, 2020

Tecartus Approved for Treatment of Mantle Cell Lymphoma

MONDAY, July 27, 2020 -- Tecartus (brexucabtagene autoleucel) received approval for the treatment of mantle cell lymphoma (MCL) in patients who have not responded to other treatment types or relapsed following treatment, the U.S. Food and Drug Administration announced Friday.

Tecartus is a chimeric antigen receptor (CAR) T cell therapy and the first cell-based gene therapy approved for the treatment of MCL. Each dose of the drug is customized based on a patient's immune system.

July 8, 2020

FDA Approves Oral Treatment for Myelodysplastic Syndrome

WEDNESDAY, July 8, 2020 -- The U.S. Food and Drug Administration has approved Inqovi (decitabine and cedazuridine) tablets, an oral outpatient treatment option for patients with myelodysplastic syndromes and chronic myelomonocytic leukemia, the agency announced Tuesday.

Inqovi provides another option for patients who previously needed intravenous therapy and will reduce the need for them to frequently visit health care facilities. The tablet is taken once daily for five consecutive days in a 28-day cycle.

July 7, 2020

Rukobia Approved for Patients With Multidrug-Resistant HIV

TUESDAY, July 7, 2020 -- A new type of antiretroviral medication, Rukobia (fostemsavir), has been approved for people with HIV who have not had success with other therapies, the U.S. Food and Drug Administration announced Thursday.

Rukobia, 600 mg extended-release tablets that are taken twice daily, is part of a new class of antiretroviral treatments for those with multidrug-resistant HIV due to resistance, intolerance, or safety considerations.

June 14, 2020

FDA OKs Second Treatment for Neuromyelitis Optica Spectrum Disorder

SUNDAY, June 14, 2020 -- Uplizna (inebilizumab-cdon) injection is now approved to treat neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody positive, the U.S. Food and Drug Administration announced Thursday.

Uplizna, approved for intravenous use, is the second treatment for NMOSD approved within the past year. There are an estimated 4,000 to 8,000 patients with NMOSD in the United States, the agency noted.

June 1, 2020

Tauvid Receives Approval for Tau Pathology Imaging

MONDAY, June 1, 2020 -- Tauvid (flortaucipir F18), a radioactive diagnostic agent, was approved to image tau pathology in patients with cognitive impairment being evaluated for Alzheimer disease, the U.S. Food and Drug Administration announced Thursday.

The drug is indicated for positron emission tomography (PET) imaging to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs). Tauvid is delivered via intravenous injection and binds to brain sites associated with the tau protein, which can be identified through PET scan imaging.

May 27, 2020

VESIcare LS Approved for Neurogenic Detrusor Overactivity

WEDNESDAY, May 27, 2020 -- VESIcare LS (solifenacin succinate) oral suspension is now approved to treat neurogenic detrusor overactivity (NDO) in children 2 years and older, the U.S. Food and Drug Administration announced Tuesday.

VESIcare (solifenacin succinate) tablets were approved in 2004 to treat overactive bladder in patients 18 years and older. VESIcare LS is the first FDA-approved treatment for NDO in patients as young as 2 years and requires only once-daily dosing as opposed to the current standard treatment, which requires dosing up to three times a day, according to Christine P. Nguyen, M.D., acting director of the FDA Division of Urology, Obstetrics and Gynecology in the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the Center for Drug Evaluation and Research.

May 27, 2020

FDA Approves IV Artesunate for Severe Malaria

WEDNESDAY, May 27, 2020 -- Intravenous (IV) artesunate received approval from the U.S. Food and Drug Administration to treat adults and children with severe malaria, the agency announced Tuesday.

This approval marks the first for severe malaria since the marketing of quinine was discontinued in early 2019. Before the current approval, U.S. patients with severe malaria and those with uncomplicated malaria who were not able to take oral medications were treated with IV artesunate under an investigational new drug protocol through the FDA Expanded Access program.

May 18, 2020

Qinlock Approved as Fourth-Line Treatment for GIST

MONDAY, May 18, 2020 -- The U.S. Food and Drug Administration approved Qinlock (ripretinib) tablets as a fourth-line treatment for adults with advanced gastrointestinal stromal tumors (GISTs), the agency announced Friday.

The approval follows four other FDA-approved target therapies for GIST, including imatinib in 2002, sunitinib in 2006, regorafenib in 2013, and avapritinib in January. Qinlock is indicated for patients who have received at least three kinase inhibitor therapies, including imatinib.