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Regulatory Focus™ > News Articles > 2020 > 9 > FDA Approvals Roundup: Detectnet, Nityr, Trelegy Ellipta

FDA Approvals Roundup: Detectnet, Nityr, Trelegy Ellipta

Posted 16 September 2020 | By Renee Matthews 

FDA Approvals Roundup: Detectnet, Nityr, Trelegy Ellipta

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals
Detectnet okayed for locating neuroendocrine tumors during PET
RadioMedix’s Detectnet (copper Cu 64 dotatate injection) has been approved for the detection of somatostatin receptor‒positive neuroendocrine tumors (NETs) in adult patients during imaging with positron emission tomography.
Approval for the radioactive diagnostic agent was supported by findings from two trials that evaluated image sensitivity and specificity in 175 patients who underwent PET screening. Trial 1 included 63 patients at a single center, some of whom had known or suspected NETs and others who did not. The PET images were compared with a composite reference standard. Trial 2 analyzed existing data from a single-center study of 112 patients with a history of NETs and compared the imaging with other imaging and biopsy.
 “The phase III results demonstrate the clinical sensitivity and specificity of Detectnet, which will provide a great aid to clinicians in developing an accurate treatment approach for their NET patients,” said Ebrahim Delpassand, MD, chief executive officer of RadioMedix. “Perhaps most exciting is that the 12.7-hour half-life allows [the copper Cu 64 dotatate injection] to be produced centrally and shipped to sites throughout the US. This will help alleviate shortages or delays … with other somatostatin analogue PET agents.”
New indications
Nityr approved as once-daily regimen for incurable genetic disorder
Cycle Pharmaceuticals’ Nityr (nitisinone tablet) has received approval as a once-daily dosing regimen for treating hereditary tyrosinemia type 1 (HT-1) in patients aged 5 years or older. Patients can switch to the new dosage after they have undetectable serum and urine succinylacetone concentrations being on a stable, twice-daily dosage of the drug for a minimum of 4 weeks.
HT-1 is a rare, incurable, and potentially fatal metabolic disorder in which patients cannot produce enough of the enzyme fumarylacetoacetate hydrolase, which metabolizes the amino acid tyrosine. Accumulation of tyrosine and other toxic substances damages the liver, kidneys, and peripheral nerves. Nityr, in combination with dietary restriction of tyrosine and phenylalanine, prevents that accumulation.
The drug was originally approved in 2002 as a twice-daily therapy.
Trelegy Ellipta nabs expanded indication for adults with asthma
GlaxoSmithKline’s Trelegy Ellipta (fluticasone furoate-umeclidinium-vilanterol inhalation powder) has received a new indication as a single-dose, once-daily treatment for asthma in patients aged 18 years or older.
Trelegy was approved in the US in 2017 as a once-daily, long-term maintenance therapy for patients with chronic obstructive pulmonary disease. Its approval for asthma makes it the first single-inhaler triple therapy approved for both conditions. It is not approved for relief of acute bronchospasm.
Approval for the asthma indication was based on data from the CAPTAIN study. The randomized, double-blind, active controlled, six-arm parallel group study evaluated 2,436 patients whose asthma was uncontrolled on long-acting beta agonists and inhaled corticosteroids. Findings showed that the additional bronchodilation with Trelegy resulted in improved lung function compared with the fluticasone furoate-vilanterol combination.
Qdolo approved in oral solution form for severe pain
Athena Bioscience’s Qdolo (tramadol hydrochloride, 5 mg/mL oral solution) has been approved for treating adults with severe pain that has not responded to other available therapies.
The opioid agonist received previous approval in extended-release capsule form for the same indication. It comes with a boxed warning for addiction, abuse, and misuse. As with all opioid analgesics, the FDA requires a risk evaluation and mitigation strategy for the therapy.
“As an oral liquid, Qdolo gives physicians flexibility to titrate dosing precisely according to individual patients’ needs,” said Jeff Bryant, president and CEO of Athena Bioscience. “In addition, for patients with swallowing disfunction [dysphagia] or who simply have trouble swallowing pills, Qdolo provides an essential alternative to other forms of tramadol.”

Tags: FDA, US

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