Briefs
Italfarmaco Gains Rare Pediatric Disease Designation for Drug Treating Duchenne Muscular Dystrophy
The FDA has granted Italfarmaco a Rare Pediatric Disease designation for Givinostat, its investigational treatment for young males suffering from Duchenne Muscular Dystrophy.
In April, Italfarmaco disclosed positive interim study data indicating a slower disease progression in young males treated with Givinostat and steroids. The company said it has now completed enrollment of 179 participants for a phase 3 trial and expects to release first results in June 2022.
Givinostat previously received Orphan Drug and Fast-Track designations from the FDA.
Eli Lilly to Help Supply COVID-19 Antibody Treatment to Poorer Countries
Eli Lilly has entered an agreement with the Bill and Melinda Gates Foundation to help ensure lower-income nations have access to its COVID-19 monoclonal antibody treatment.
The arrangement is part of the foundation’s COVID-19 Therapeutics Accelerator program, an effort to speed up research, development and delivery of coronavirus treatments. Under the agreement, Lilly’s monoclonal antibody, which is awaiting an FDA decision on Emergency Use Authorization (EUA), will be manufactured at the Fujifilm Diosynth Biotechnologies facility in Denmark beginning in April 2021.
Lilly said it will contribute certain amounts of its antibody manufactured at other facilities prior to that date, though it did not specify numbers. The company recently said it would have up to one million doses of the monoclonal antibody available by year’s end.
Pfizer’s Cancer Med Ibrance Fails in Late-Stage Breast Cancer Trial
Pfizer announced that a phase 3 trial of its targeted breast cancer therapy Ibrance (palbociclib) failed to meet its primary endpoint of improved invasive disease-free survival in women with a certain form of breast cancer.
The trial evaluated one year of the drug with at least five years of standard adjuvant endocrine therapy compared to placebo. It failed to improve invasive disease-free survival in women with hormone receptor-positive, human epidermal growth factor-negative, early breast cancer who have residual invasive disease after completing neoadjuvant chemotherapy.
“While we are disappointed with this result, we look forward to continuing to work with our research partners to understand subgroup data” and how these could help in developing cyclin-dependent kinase (CDK) inhibitors to treat early breast cancer, said Chris Boshoff, Pfizer Oncology’s chief development officer.
Russia Begins Human Trials in UAE for COVID-19 Vaccine
A late-stage trial of Russia’s Sputnik V COVID-19 neutralizing antibody vaccine is now underway in the United Arab Emirates, the Kremlin said.
Developed by Moscow’s Gamaleya Institute, Sputnik V came under fire internationally when the government approved it before the start of phase 3 trials.
Phase 3 trials of Sputnik V are ongoing in Russia, Saudi Arabia, Belarus and the Philippines, and additional trials are planned in India and Venezuela.
Alexion Gains Expanded Approval for Blood Disorder Drug
Alexion Pharmaceuticals has received FDA approval for a 100 mg/mL formulation of Ultomiris (ravulizumab-cwvz) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
The Boston, Mass., drugmaker says the new formulation of Ultomiris reduces infusion time by 60 percent vs. the 10 mg/mL version, with patients estimated to spend an annual six hours or fewer undergoing treatment.
PNH is a blood disorder associated with a range of symptoms such as thrombosis which can lead to organ damage and death. Linked with PNH and other co-morbidities, aHUS can lead to renal failure.
Alexion has filed marketing applications for the new formula with the EU and Japan and expects a decision from the European Commission next month.
Novavax Developing Combination Flu, COVID-19 Vaccine
Novavax said it will look into developing a combined influenza/COVID-19 vaccine for post-pandemic use that would unite two of its vaccine candidates.
The company is currently seeking FDA approval of the influenza vaccine, NanoFlu, supported by positive results from a phase 3 trial. The Maryland-based company is also developing a coronavirus vaccine, NVX-CoV2373.
A late-stage trial of NVX-CoV2373 is expected to get under way in late November and produce efficacy data around March 2021. The company has created a new team that will explore a combined product.
Pharmacists Warn of Influx of Counterfeit Medicines in UK
The Royal Pharmaceutical Society of Great Britain has called on the UK government to take aggressive steps to prevent an influx of counterfeit medicines to the country following Brexit.
In a letter to UK Health Secretary Matt Hancock, the society said immediate plans must be put in place to maintain strong ties with the EU so that the normal authentication of medicines can continue beyond Dec. 31.
As it stands, the UK will no longer directly benefit from the EU’s Falsified Medicines Directive post-Brexit, and the society warned that counterfeit medicines could invade the supply chain and negatively impact patient care.
HHS Partners with Cytiva for COVID-19 Vaccine Components
Cytiva has finalized a $31 million deal with HHS’ Biomedical Advanced Research and Development Authority to develop and manufacture COVID-19 vaccine component parts.
The contract, which is part of the administration’s Operation Warp Speed initiative to accelerate access to COVID-19 vaccines, stipulates that Cytiva will expand its Massachusetts manufacturing facility and build a new plant in Utah to supply cell culture media, cell culture buffers, mixer bags and bioreactors.
The U.S. government has allocated more than $1.1 billion to expand U.S. manufacturing capabilities for COVID-19 treatments and for the needles, syringes, vials and other materials needed for vaccinations.
“As part of Operation Warp Speed, we are expanding U.S.-based manufacturing of the products that are essential in the development and manufacturing of COVID-19 vaccines,” said HHS Secretary Alex Azar.
Russia Approves Second COVID-19 Vaccine
Russia has approved a second COVID-19 vaccine, the EpiVacCorona vaccine developed at the Vector Institute in Siberia.
The approval was granted ahead of a planned 30,000-participant phase 3 trial.
In August, Russian approved Sputnik V, the world’s first COVID-19 vaccine, prompting international concern because it had not gone through a late-stage study. Sputnik V is currently undergoing phase 3 trials in Russia, Saudi Arabia, Belarus and the Philippines.
World Bank Allocates $12 Billion for COVID-19 Vaccines in Developing World
The World Bank has approved $12 billion to help low-income countries combat COVID-19 and protect their citizens.
The financing, which aims to support vaccination of up to 1 billion people, is part of the global organization’s $160 billion plan allocated through June 2021 to promote coronavirus prevention and treatments.
The $12 billion will provide COVID-19 treatments and tests and assist with supply-chain and logistics management, such as implementing proper vaccine storage, hiring trained vaccinators and creating large-scale community outreach.
FDA Releases MAPP for Generic Drug Suitability Petitions
The FDA has issued a revised manual of policies and procedures (MAPP) explaining the three conditions under which it will deny a suitability petition for applicants submitting abbreviated new drug applications (ANDAs).
Suitability petitions are sent in by applicants seeking permission to submit an ANDA for a generic drug product that differs from a reference listed drug (RLD) in the route of administration, dosage form or strength, or a generic that has one different active ingredient in a fixed-combination drug product.
The agency said it will approve a suitability petition unless it needs data from investigations beyond the scope of an ANDA, if a drug product is approved in a new drug application (NDA) for the change requested in the petition, or if the petition seeks changes to a drug product that require pediatric studies that cannot be waived.
Read the MAPP here: www.fdanews.com/MAPP-5240-5r2.pdf.
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