The FDA has granted orphan drug and rare pediatric disease designations to Spirovant Sciences's SPIRO-2101, an inhaled adeno-associated virus (AAV) gene therapy for the treatment of cystic fibrosis, the company said. SPIRO-2101 works by replacing defective cystic fibrosis transmembrane conductance regulator (CFTR) genes and is meant for CF patients who are unable to … [Read more...] about Spirovant’s inhaled gene therapy for CF gets orphan drug and rare pediatric disease designations
Regulatory
FDA issues minor CRL regarding Hikma’s ANDA for generic version of Advair Diskus
Hikma Pharmaceuticals and Vectura announced that the FDA has issued a minor complete response letter regarding Hikma's ANDA for VR315 fluticasone propionate/salmeterol DPI, a generic version of GSK’s Advair Diskus. The companies say that they "are committed to bringing this important product to the US market and remain confident in the submission." Hikma said that … [Read more...] about FDA issues minor CRL regarding Hikma’s ANDA for generic version of Advair Diskus
FDA approves Trelegy Ellipta for the treatment of asthma
GlaxoSmithKline and Innoviva have announced that the Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol DPI has been approved by the FDA for the treatment of asthma in adult patients. The approved doses for the treatment of asthma are 100/62.5/25 mcg and 200/62.5/25mcg FF/UMEC/VI. The FDA approved Trelegy Ellipta for the treatment of COPD in September … [Read more...] about FDA approves Trelegy Ellipta for the treatment of asthma
Marinomed submits MAA for xylometazoline decongestant nasal spray
Marinomed Biotech said that it has submitted an MAA via the decentralized marketing authorization procedure for a xylometazoline decongestant nasal spray formulated with the company's Carragelose red algae extract. The company currently markets a range of non-prescription nasal sprays based on Carragelose, including Coldamaris; the xylometazoline spray will be its … [Read more...] about Marinomed submits MAA for xylometazoline decongestant nasal spray
FDA agrees to new Phase 2 trial design for Aridis’ AR-501 inhaled gallium for CF
According to Aridis Pharmaceuticals, the FDA has agreed to allow a Phase 2a trial of the company's AR-501 nebulized formulation of gallium citrate for the treatment of lung infections in cystic fibrosis patients to skip a SAD study and move directly into a multiple ascending dose study. Aridis said that it proposed the new design after successfully completing a Phase … [Read more...] about FDA agrees to new Phase 2 trial design for Aridis’ AR-501 inhaled gallium for CF
FDA publishes product specific draft guidances for esketamine and sumatriptan nasal sprays
Esketamine (Spravato) and sumatriptan (Tosymra) nasal sprays are among the latest set of product specific draft guidances published by the FDA. Earlier this year, the agency published a product specific guidance for sumatriptan nasal powder. The August 2020 revised product guidances include budesonide nasal spray and ketorolac tromethamine nasal spray. In … [Read more...] about FDA publishes product specific draft guidances for esketamine and sumatriptan nasal sprays
Lupin’s generic version of ProAir HFA approved by the FDA
The FDA has approved Lupin's generic version of Teva's ProAir HFA albuterol MDI for the treatment of asthma, the company said. Lupin said that it will manufacture the inhaler at its facility in Indore, India. Lupin CEO Vinita Gupta commented, “Approval of our generic albuterol MDI is a significant milestone in our complex generics evolution and a validation of … [Read more...] about Lupin’s generic version of ProAir HFA approved by the FDA
United Therapeutics submits sNDA for use of Tyvaso in PH-ILD
The FDA has accepted a supplemental NDA for United Therapeutics's Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), the company said. In February 2020, United Therapeutics announced that the Phase 3 INCREASE study of Tyvaso in PH-ILD patients had met its primary endpoint. Tyvaso … [Read more...] about United Therapeutics submits sNDA for use of Tyvaso in PH-ILD
NeuroRx gets clearance for clinical trial of inhaled aviptadil for COVID-19
The FDA has cleared an IND for NeuroRx to conduct a clinical trial of an inhaled formulation of its RLF-100 aviptadil in patients with moderate or severe COVID-19, the company said. NeuroRx recently announced that an intravenous formulation of RLF-100 has shown promising results in patients with severe COVID-19 and that researchers in Brazil have demonstrated that … [Read more...] about NeuroRx gets clearance for clinical trial of inhaled aviptadil for COVID-19
Atossa gets approval for Phase 1 study of AT-301 nasal spray
Atossa Therapeutics said that it has gotten the go-ahead for a Phase 1 clinical study of its AT-301 nasal spray, which the company is developing for the treatment of COVID-19, and expects to begin enrollment within a month. Atossa previously announced that it had contracted with Summit Biosciences for development and manufacturing of the nasal spray and with Advance … [Read more...] about Atossa gets approval for Phase 1 study of AT-301 nasal spray