Market Place
Dexamethasone benefits severely ill Covid patients; FDA warning letter to Takeda’s sterile operations in Japan
This week, Phispers brings you more news on hydroxychloroquine (HCQ) as the US Food and Drug Administration withdrew its Emergency Use Authorization for Covid-19. The FDA also warned healthcare providers about a newly discovered potential drug interaction related to remdesivir. Oxford’s study on steroidal drug dexamethasone saw a reduction in death in patients with severe Covid-19.
In vaccine developments, the German government picked up stake in CureVac, AstraZeneca assured supplies of a possible Covid vaccine to Europe and Chinese state-run drug company — Sinopharma — said an inactivated Covid-19 vaccine triggered a strong neutralizing antibody response in a phase 1/2 study.
While Merck’s Gardasil bagged FDA approval for head and neck cancer, Novo Nordisk acquired AstraZeneca’s spinoff Corvidia Therapeutics for US$ 2.1 billion. In a third generic drug price fixing lawsuit in US, 26 drugmakers were sued last week by the attorneys general of most states and several territories for conspiring to reduce competition and drive up generic drug prices. And, FDA issued a warning letter to Japanese drugmaker Takeda for violating good manufacturing practices.
HCQ: FDA withdraws Emergency Use Authorization, WHO drops it from Covid trial
Since the beginning of the Covid-19 pandemic outbreak, one drug has dominated headlines, and that’s hydroxychloroquine (HCQ). In another significant development regarding the drug, this week the US Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) for HCQ to treat Covid-19 patients amid growing evidence that the drug’s potential benefits do not outweigh its risks.
Following the FDA announcement, the World Health Organization (WHO) said it was dropping the drug from its massive study investigating treatments after available data indicated the drug was not effective for Covid-19.
HCQ gained attention as a potential Covid-19 treatment in February, when some studies suggested it might be useful against the virus. The EUA was first issued in March, and the drug was administered to patients hospitalized with Covid-19 and to those in clinical trials.
The FDA said the revocation of EUA will not affect clinical trials, which are expected to continue.
“Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat Covid-19 and that the drug’s potential benefits for such use do not outweigh its known and potential risks.” the FDA has said.
After revoking the EUA, the FDA also warned healthcare providers about a newly discovered potential drug interaction related to investigational antiviral drug remdesivir, which has also received EUA for the treatment of hospitalized Covid-19 patients with severe disease.
In a factsheet for healthcare providers, FDA has stated that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir.
Oxford study sees severely ill Covid-19 patients benefit from dexamethasone
Last week, we had carried news that UK’s randomized clinical trial RECOVERY to test a range of potential treatments for Covid-19 had found hydroxychloroquine (HCQ) to be “useless”. This week, there is more news from the RECOVERY trial — low-dose dexamethasone (a steroid treatment) reduces death in patients with severe Covid-19.
The study, led by the University of Oxford, was a large, strict test that randomly assigned 2,104 patients to get the drug and compared them with 4,321 patients getting only usual care. Researchers said they would publish the results in a medical journal soon.
The drug was given either orally or intravenously for 10 days. After four weeks, it had reduced deaths by 35 percent in patients who needed treatment with breathing machines and by 20 percent in those only needing supplemental oxygen. It did not appear to help less ill patients. Dexamethasone is a widely used and affordable drug used to treat conditions such as rheumatoid arthritis, asthma, and some cancers.
This is the first time a therapy has been shown to possibly improve the odds of survival with the condition in the sickest patients. The results were announced Tuesday and the British government immediately authorized the drug’s use across the UK for Covid-19.
England’s Chief Medical Officer Chris Whitty has hailed the finding as the most important trial result so far, as scientists seek effective treatments for the new disease.
“Early on, you’re fighting the virus and you want your immune system to be as intact as possible”, Anthony Fauci, America’s infectious disease expert and immunologist said. But in the advanced stage of Covid-19, the battle against the virus causes so much inflammation that it “is hurting you more than helping you...” he said. The results seen in the Oxford study make “perfect sense” with that notion, Fauci added.
Meanwhile, the WHO has said it is looking forward to the full data analysis of the dexamethasone study in the coming days. “WHO will coordinate a meta-analysis to increase our overall understanding of this intervention,” the agency said in a statement.
Merck’s Gardasil bags FDA approval for head and neck cancer
Last week, the US Food and Drug Administration (FDA) granted approval to the latest version of Gardasil, the human papilloma virus (HPV) vaccine, to prevent an epidemic of throat cancer that affects 13,500 Americans each year. The decision was announced by Merck, the company that makes Gardasil.
Speaking on the latest version of the vaccine — Gardasil 9, Marshall Posner, the director of head and neck medical oncology at the Tisch Cancer Institute, said the approval is “a good thing for the FDA to do” and that he would be “thrilled” if head and neck cancer cases could be reduced through vaccination in coming decades.
The original version of the Gardasil vaccine was approved in 2006 for girls and women between the ages of 9 and 26 based on data from clinical trials that showed how the vaccine, by preventing HPV infection, could also prevent precancerous cervical lesions.
Vaccine update: Germany picks stake in CureVac, AstraZeneca assures supplies to Europe
As pressure on Covid-19 vaccine supplies grows, governments across the world are looking at securing supplies as soon as a candidate clears all clinical trials. In the latest development, the German government is investing US$ 338.5 million (Euro 300 million) in a 23 percent stake in CureVac to help the biotech fund the Covid-19 vaccine. The deal values the firm at around US$ 1.46 billion (Euro 1.3 billion).
This move by the German government follows reported attempts by the US government to acquire CureVac or its assets in March, which led to a backlash in Germany.
CureVac is also planning an initial public offering in the US next month. German biotech firms BioNtech and Morphosys also sought US listings recently.
Germany’s investment in CureVac comes days after it signed an agreement along with other countries of Europe’s Inclusive Vaccine Alliance (IVA) to procure up to 400 million doses of a potential Covid-19 vaccine from AstraZeneca. This was the first contract signed by IVA, a group formed by France, Germany, Italy and the Netherlands, to secure vaccine doses for all EU member states as soon as possible.
With two German vaccine developers — CureVac and BioNTech — working on coronavirus vaccines, the government in Germany gave itself new powers last month to reject foreign takeover bids for healthcare companies.
Meanwhile, the European Commission received a mandate from EU governments last week to negotiate advance purchases of promising Covid-19 vaccines. EU health ministers backed the Commission’s plan to use an emergency fund of US$ 2.7 billion (Euro 2.4 billion) to buy coronavirus vaccines upfront. Under the plan, the EU would use most of the money available in that fund to buy in advance up to six vaccines for its 450 million people.
Chinese vaccine shows positive results in phase 1/2 study
This week, a state-run drug company in China — Sinopharma — said an inactivated Covid-19 vaccine developed by its subsidiary China National Biotec Group’s (CNBG) Wuhan Institute of Biological Products triggered a strong neutralizing antibody response in a phase 1/2 study.
The company said the vaccine appeared to work best at the middle strength when given 28 days apart, as all participants in that dosing schedule developed neutralizing antibodies that can defend a cell from infection.
As of today, all 1,120 volunteers in the phase 1/2 trial have received two injections of the vaccine at low, middle or high dosing strengths—or placebo—either 14 days, 21 days or 28 days apart, according to CNBG. The seroconversion rate for the 14-day and 21-day schedule of the mid-dose was 97.6 percent. At 28 days, it was 100 percent.
The vaccine is one of the two inactivated shots CNBG is working on. The Wuhan version went into clinical trials on April 12, and another developed by its Beijing institute entered human testing in late April. Through two new vaccine production facilities in Beijing and Wuhan, CNBG is aiming to produce 200 million doses of inactivated Covid-19 vaccines a year.
Novo Nordisk acquires AstraZeneca’s spinoff Corvidia for US$ 2.1 billion
Last week, European Lifesciences venture capital firm Sofinnova Partners announced the sale of its portfolio company Corvidia Therapeutics to Novo Nordisk, for US$ 2.1 billion, including an upfront payment of US$ 725 million.
Founded in 2015, Corvidia is an AstraZeneca spin-off and a clinical-stage company focused on the research, development and commercialization of therapies for cardio-renal diseases.
At the heart of the deal is Corvidia’s lead experimental drug — an IL-6 inhibitor, ziltivekimab, carved out of AstraZeneca’s pipeline. It is currently in mid-stage development to reduce the risk of major cardiovascular events in patients with chronic kidney disease.
Third generic drug price fixing lawsuit in US names 26 drugmakers
In the US, 26 drugmakers were sued last week by the attorneys general of most states and several territories. They accused these companies of conspiring to reduce competition and drive up generic drug prices.
The lawsuit accused Novartis’ Sandoz unit, Teva Pharmaceuticals’ Actavis unit, Mylan, Pfizer and several other drugmakers of conspiring to manipulate the market for over 80 drugs between 2009 and 2016. The attorneys general also named 10 executives for their conspiracy to fix drug prices.
At the centre of the complaint are topical drugs such as creams, gels, lotions, ointments, shampoos, and solutions used to treat a variety of skin conditions, pain, and allergies. Some of the brand names in the lawsuit include glaucoma drug Xalatan, acne drug Differin, anti-seizure medicine Dilantin, anti-fungal medicine Lotrimin AF Cream, and Ritalin for attention deficit disorder.
The lawsuit stems from an ongoing antitrust investigation “into a widespread conspiracy by generic drug manufacturers to artificially inflate and manipulate prices, reduce competition, and unreasonably restrain trade for generic drugs sold across the United States.”
Meanwhile, the US Supreme Court this week declined to hear generic drugmakers’ challenge to a court order requiring them to turn over millions of pages of records to states and drug purchasers accusing them of fixing prices.
Lawyers for drugmakers such as Teva, Mylan, Amneal Pharmaceuticals and others had petitioned the Supreme Court to overturn an “extraordinary order” from a district judge requiring the companies to turn over records without reviewing them for relevance first.
FDA issues warning letter to Japanese drugmaker Takeda
Last week, the US Food and Drug Administration (FDA) issued a warning letter to Japanese drugmaker Takeda Pharmaceutical for violation of good manufacturing practices (GMP) observed during an inspection of its Hikari, Yamaguchi facility in November 2019.
The FDA warning letter cites three violations relating to the firm’s procedures for aseptic manufacturing and investigations into unexplained discrepancies and equipment malfunctions.
“Our inspection found that your Quality Unit (QU) did not take appropriate steps prior to resumption of aseptic manufacturing after a shutdown that included multiple significant activities that compromised your cleanroom control”, the FDA letter said.
The agency said Takeda allowed manufacturing operations to resume without performing media fills as required in its procedures and shipped multiple batches of affected products to the US.
In addition, the FDA said it wants Takeda to provide a “comprehensive assessment and remediation plan” to ensure its QU has the authority and resources to function effectively, as well as a “description of how top management supports quality assurance and reliable operations”.
The warning letter also notes that Takeda “failed to establish and follow appropriate written procedures that are designed to prevent microbial contamination of drug products purporting to be sterile.”
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