Regulatory Focus™ > News Articles > 2020 > 6 > FDA Approvals Roundup: Tauvid, Oriahnn, Sirturo

FDA Approvals Roundup: Tauvid, Oriahnn, Sirturo

Posted 03 June 2020 | By Renee Matthews 

FDA Approvals Roundup: Tauvid, Oriahnn, Sirturo

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals

Tauvid nabs approval as first drug to aid imaging of tau pathology
FDA has approved Avid Radiopharmaceuticals’ radioactive diagnostic agent Tauvid (flortaucipir F18 injection) as the first drug to image tau pathology, a distinctive characteristic of Alzheimer’s disease in the brain.
The drug is indicated for intravenous administration before positron emission tomography (PET) imaging of the brain in adult patients with cognitive impairment who are being evaluated for the disease.
The agency gave the application priority review status to expedite the review process because it deemed the drug would have a significant impact on the evaluation of this patient population.
Another protein, amyloid, is also associated with Alzheimer’s disease. Three imaging agents have been approved for imaging amyloid pathology with PET scans: Neuraceq (florbetaben F18), approved in 2014; Vizamyl (flutemetamol F18) in 2013; and Amyvid (florbetapir F18) in 2012.
Tauvid’s safety and effectiveness was evaluated in two clinical studies. One study showed a high probability with Tauvid imaging of accurate evaluation of the indicated population and an average-to-high probability of correctly evaluating those with no tau pathology. Another study focused on the extent of reader agreement among the evaluators (1 = perfect agreement; 0 = no agreement). Those findings showed agreement of 0.87 across all participants (n = 241). A subanalysis of evaluator agreement in terminally ill patients and those with cognitive impairment showed agreement at 0.82 and 0.90, respectively.
Oriahnn okayed as first oral therapy for fibroid-related bleeding
AbbVie’s Oriahnn (elagolix, estradiol and norethindrone acetate capsules; elagolix capsules), has been approved by FDA as the first drug for the management of heavy menstrual bleeding in premenopausal women with uterine leiomyomas, or fibroids.
The drug label includes a boxed warning about the risk of vascular events and thrombotic or thromboembolic disorders, especially in women at risk for those events.
New indications

Sirturo for children with pulmonary multidrug-resistant TB
A new pediatric formulation of Janssen Pharmaceuticals’ Sirturo (bedaquiline) has been approved by FDA as part of a combination therapy for pulmonary multidrug-resistant tuberculosis (MDR‑TB) in adults and children aged 5 years or older.
Janssen said in a statement the therapy should be used in the US only when no other effective regimen is available. The approval is seen as a boost to global efforts to treat MDR-TB in vulnerable populations in high-burden countries.
The application for the pediatric formulation obtained priority review from the agency. The indication received accelerated approval based on time to sputum culture conversion. The company noted that continued approval for the indication would be contingent on the verification and description of the drug’s clinical benefits in confirmatory trials.
This was the first regulatory approval for the pediatric formulation of Sirturo. It originally received accelerated approval in 2012 for adult patients with MDR-TB and was approved in tablet form in 2019 as part of combination therapy in adolescent patients (aged 12 to under 18 years) with pulmonary MDR-TB. Research is underway in children aged 2-4 years and in infants younger than 2 years.
Taltz for nonradiographic axial spondyloarthritis
FDA has approved a supplemental biologics license application for Eli Lilly’s Taltz (ixekizumab) by extending use of the therapy to nonradiographic axial spondyloarthritis (nr-axSpA) in patients aged 6 years or older.
The approval makes Taltz the first IL-17A antagonist approved for that form of axial spondyloarthritis, meaning it can now be used to treat patients across the full axSpA spectrum. It was approved in 2019 as a therapy for ankylosing spondylitis, which is also known as radiographic axSpA.
The drug was first approved in 2016 for treating moderate to severe plaque psoriasis in adult candidates for systemic therapy or phototherapy, then twice in 2017, as a therapy for adults with active psoriatic arthritis and for the treatment of adults with active ankylosing spondylitis.
Nivolumab-ipilimumab with chemo for metastatic lung cancer
FDA has approved a combination of Bristol-Myers Squibb’s Opdivo and Yervoy (nivolumab and ipilimumab), plus 2 cycles of platinum-doublet chemotherapy, as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer who do not have EGFR or ALK genomic tumor aberrations.
The agency said in a statement the review application was in collaboration with its Project Orbis counterparts – the Australian Therapeutic Goods Administration (TGA), Health Canada and Singapore’s Health Sciences Authority (HSA). The project was launched in 2019 as a collaborative review effort between participating agencies. The FDA and HSA decisions are “near-simultaneous,” according to FDA, while the application review for TGA and Health Canada is still underway.
The application was reviewed under FDA’s real-time oncology review (RTOR) pilot to streamline data submission ahead of the complete application and received assessment aid. This application had also been granted priority review and fast track designations.
Tecentriq-Avastin combination for unresectable hepatocellular carcinoma
FDA has approved Roche’s Tecentriq (atezolizumab) combined with Avastin (bevacizumab) as a therapy for patients with unresectable or metastatic hepatocellular carcinoma who have not undergone previous treatment.
FDA collaborated with its Project Orbis partners – the Australian TGA, Health Canada and Singapore’s HSA – on the review of the Tecentriq application, which remains ongoing for the other three regulators. The review used the RTOR and featured assessment aid, to speed up and facilitate the process.
The applications were given priority review status, and both drugs were granted breakthrough designations.
Cyramza plus Tarceva for first-line metastatic, EGFR-mutated lung cancer
Eli Lilly’s Cyramza (ramucirumab), in combination with Astellas’ Tarceva (erlotinib), has been approved by FDA as a first-line therapy for metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) mutations. The review used assessment aid to facilitate the assessment process.
Cyramza is a human monoclonal antibody that acts as a direct VEGFR2 antagonist. It has received previous approvals for gastric cancer and NSCLC in 2014, colorectal cancer in 2015 and hepatocellular carcinoma in 2019.
Zilxi for inflammatory lesions in rosacea
FDA has approved Menlo Therapeutics’ Zilxi (minocycline) topical foam, for the treatment of inflammatory lesions of rosacea in adults. It is the first minocycline product approved for use in rosacea.
Minocycline is a broad-spectrum antibiotic known as a tetracycline and has anti-inflammatory properties. Zilxi contains Menlo’s proprietary molecule stabilizing technology to deliver the drug in a foam-based vehicle.
The company expects the therapy will be available for prescribing by the fourth quarter of this year.
Brilinta for reducing myocardial infarction, stroke in CAD
AstraZeneca’s Brilinta (ticagrelor), in combination with aspirin, has been approved by FDA to reduce the risk of a first myocardial infarction or stroke in high-risk patients with coronary artery disease (CAD).
The approval was based on findings from the THEMIS trial. Other regulatory submissions to expand the approved indication, based on the same findings, are under review in the European Union, Japan and China.


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.