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NEW YORK, Dec. 02, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited(Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for remestemcel-L in the treatment of acute respiratory distress syndrome (ARDS) due to COVID-19 infection. Fast Track designation is granted if a therapy demonstrates the potential to address unmet medical needs for a serious or life-threatening disease.¹ ARDS is the primary cause of death in patients with COVID-19.

Fast Track designation by the FDA is intended to facilitate development and expedite review of therapies to treat serious and life-threatening conditions with no or limited treatment options so that an approved product can reach the market expeditiously.¹ Under Fast Track designation, a Biologic License Application (BLA) for remestemcel-L is eligible for both rolling submission and priority review.

Clinical data provided to the FDA supporting the potential of remestemcel-L to address the unmet medical need of COVID-19 ARDS included results from a pilot study of remestemcel-L under emergency compassionate use at New York’s Mt Sinai Hospital in March-April this year. In this study, nine of 12 ventilator-dependent patients (75%) with moderate to severe COVID-19 ARDS were successfully discharged from hospital a median of 10 days after receiving two intravenous doses of remestemcel-L.

The ongoing randomized controlled Phase 3 trial of remestemcel-L in up to 300 ventilator-dependent patients with moderate to severe COVID-19 ARDS, under an FDA Investigational New Drug clearance, is approximately two-thirds enrolled. The trial’s primary endpoint is overall mortality at Day 30, and the key secondary endpoint is days alive off ventilatory support through Day 60. Two interim analyses have been performed by the independent Data Safety Monitoring Board (DSMB), after 90 and 135 patients were enrolled, with recommendations to continue the trial as planned. A third and final interim analysis is planned to be performed by the DSMB when 180 patients have completed 30 days of follow-up.

Mesoblast recently entered into a license and collaboration agreement with Novartis for the development, manufacture and commercialization of remestemcel-L, with an initial focus on the treatment of ARDS, including COVID-19 ARDS. The closing of the agreement is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and certain other conditions.

About COVID-19 Acute Respiratory Distress Syndrome (ARDS)
ARDS is due to a dysregulated immune response in the lungs to various infectious agents including COVID-19. Deaths continue to increase in ventilator-dependent ARDS patients as COVID-19 cases continue to surge globally. Despite improved treatment and earlier intervention in hospitalized COVID-19 patients overall, the mortality rate in COVID-19 ARDS patients who are over 60 years old remains more than 60%.² These patients appear to be particularly refractory to corticosteroids such as dexamethasone^3,4 and have not responded to single cytokine antagonists, anti-virals, or anti-malaria agents.

About Remestemcel-L
Remestemcel-L is an investigational therapy comprising culture-expanded mesenchymal stromal cells derived from the bone marrow of an unrelated donor. Remestemcel-L is thought to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by downregulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

The United Kingdom has become the first country to authorise the Pfizer-BioNTech COVID-19 vaccine for use. Britain on December 2 said that the COVID-19 vaccine will be rolled out for use from next week. The emergency authorization clears the way for the deployment of a vaccine that’s expected to play a significant role in the global effort to halt the coronavirus.

“The Government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s COVID-19 vaccine for use,” the government said.

BRUSSELS (Reuters) -The European Union has struck a deal for up to 160 million doses of U.S. firm Moderna’s COVID-19 vaccine candidate, the head of the European Commission said on Tuesday, taking the EU’s potential stock of COVID-19 shots to nearly 2 billion.

Last week, Moderna said its experimental vaccine was 94.5% effective in preventing COVID-19, based on interim data from a late-stage clinical trial.

“I am happy to announce that tomorrow we will approve a new contract to secure another COVID-19 vaccine,” Ursula von der Leyen said, adding the deal “allows us to buy up to 160 million doses of a vaccine produced by Moderna.”

Actual purchases will be carried out by EU governments if the vaccine is approved by the EU’s drug regulator.

The delivery timeline is unknown. The doses would be enough to vaccinate 80 million people as the vaccine is expected to be administered in two doses.

In August the EU’s executive Commission, which co-leads talks with vaccine makers on behalf of member states, said it had held preliminary talks with Moderna over a deal for 80 million doses and an option for 80 million more.

The terms of the contract have not been disclosed.

An EU official involved in the talks told Reuters last week the EU was seeking a price below $25 per dose for Moderna’s vaccine..

But Moderna Chief Executive Stephane Bancel said on Sunday the company would charge governments between $25 and $37 per dose, depending on the amount ordered.

A spokesman for the Commission declined to comment on pricing.

It is the sixth supply deal the EU has negotiated with COVID-19 vaccine makers and takes the total number of doses secured by the bloc to 1.96 billion for its population of around 450 million.

Brussels has already struck deals with AstraZeneca, Pfizer-BioNTech, Sanofi-GSK, Johnson & Johnson and CureVac.

It is also in talks to buy U.S. firm Novavax’s potential COVID-19 vaccine.

In its latest quarterly release of product-specific guidances meant to promote the development of generic drugs, the US Food and Drug Administration (FDA) on Wednesday posted 13 new and 21 revised draft guidances, bringing the total number of such guidances released by the agency to 1,974.

 
The guidances are intended to foster generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far this year, FDA has issued or revised more than 180 product-specific guidances.
 
Among the new and revised guidances are 11 for complex products, such as metered dose inhalers or aerosol foams, two of which FDA says were developed based on Generic Drug user Fee Amendments-funded research. FDA points out that 24 of the guidances are for products with no approved generic competition.
 
One of the new draft guidances provides recommendations for demonstrating bioequivalence for generic versions of Amphastar Pharmaceuticals’ Primatine Mist epinephrine metered dose inhaler (MDI).
 
“This is the first [product-specific guidance] PSG for an MDI product available for non-prescription over-the-counter use to temporarily relieve mild symptoms of asthma in adults and children 12 years of age and older,” FDA says. Within the guidance, FDA recommends that generic sponsors conduct five different types of in vitro bioequivalence studies, as well as pharmacokinetic bioequivalence and comparative clinical pharmacodynamic studies to support an abbreviated new drug application (ANDA).
 
The agency also released a new draft guidance for generic versions of Boehringer Ingelheim’s Spiriva Handihaler (tiotropium bromide), which is used to treat bronchospasm caused by chronic obstructive pulmonary disease (COPD). FDA says it will consider comments on the draft guidance before responding to a 2012 citizen petition filed by Boehringer that calls for the agency to apply “strict requirements” to ANDAs referencing Spiriva or any of the company’s other tiotropium products.
 

The World Health Organization recommended against using Gilead Sciences Inc.’s remdesivir to treat hospitalized Covid-19 patients less than a month after U.S. regulators granted the drug a speedy approval.

“There is currently no evidence that it improves survival or the need for ventilation,” a panel of WHO-convened experts developing Covid-19 treatment guidelines said in The BMJ medical journal

The recommendation is a blow to Gilead’s drug, which was one of the first thought to offer a meaningful benefit in treatment of coronavirus patients after a study showed it reduced their recovery time. The antiviral has been used widely to treat Covid and was among the drugs President Donald Trump received when he was diagnosed with the disease in early October.

The experts made the recommendation after the results of a global trial sponsored by the WHO, called Solidarity, found last month that remdesivir didn’t reduce deaths. They also reviewed data from three other trials and said the drug “has no meaningful effect” on the time it took patients to clinically improve.

The Solidarity results were published Oct. 15. The U.S. Food and Drug Administration approved the drug a week later, basing its decision on a trial run by the National Institutes of Health that showed remdesivir reduced hospitalized patients’ recovery time by five days.

A nasal spray that can provide effective protection against the COVID-19 virus has been developed by researchers at the University of Birmingham, using materials already cleared for use in humans, the varsity said on Thursday.

A team in the University’s Healthcare Technologies Institute formulated the spray using compounds already widely approved by regulatory bodies in the UK, Europe and the US.

The materials are already widely used in medical devices, medicines and even food products.

This means that the normal complex procedures to take a new product to market are greatly simplified, so the spray could be commercially available very quickly.

A pre-print (not yet peer-reviewed) study describes cell culture experiments designed to test the ability of the solution to inhibit infection. They found cell-virus cultures inhibited the infection up to 48 hours after being treated with the solution and when diluted many times.

Lead author on the paper, Dr Richard Moakes, said: “This spray is made from readily available products that are already being used in food products and medicines and we purposely built these conditions into our design process. It means that, with the right partners, we could start mass production within weeks.”

The spray works in two primary ways. Firstly, it catches and coats the virus inside the nose, from where it can be eliminated via the usual routes – either nose-blowing or swallowing.

Secondly, because the virus is encapsulated in the spray’s viscous coating, it is prevented from being uptaken by the body.

That means it will reduce the viral load in the body, but also even if virus particles are passed on to another person via a sneeze or cough, that person is less likely to be infected by active virus particles.

Co-author Professor Liam Grover, says: “Although our noses filter 1000s of litres of air each day, there is not much protection from infection, and most airborne viruses are transmitted via the nasal passage. The spray we have formulated delivers that protection but can also prevent the virus being passed from person to person.” The team believe the spray could be particularly useful in areas where crowding is less avoidable, such as aeroplanes or classrooms. Regular application of the spray could significantly reduce disease transmission. — PTI