EU drug agency starts evaluating new COVID-19 treatment

A sign informs people to cover mouth and nose with an FFP2 mask in front of a Covid-19 pandemic test center near Munich on Thursday amid the ongoing pandemic. (AFP)
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Updated 18 November 2021
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EU drug agency starts evaluating new COVID-19 treatment

  • Xevudy is a so-called monoclonal antibody treatment, a laboratory-made version of virus-blocking antibodies that help fight off infections
  • European Medicines Agency said it has begun evaluating an application for marketing authorization

AMSTERDAM: The European Union’s medicines authority said Thursday that it is evaluating a new drug for treating COVID-19 patients who do not require extra oxygen but are at increased risk of developing severe symptoms of the disease.
Xevudy, developed by US company Vir Biotechnology Inc. and Britain-based GlaxoSmithKline, is a so-called monoclonal antibody treatment — a laboratory-made version of virus-blocking antibodies that help fight off infections.
Antibody treatments remain one of a handful of therapies that can blunt the worst effects of COVID-19, and they are the only option available to people with mild-to-moderate cases who aren’t yet in the hospital.
The European Medicines Agency said it has begun evaluating an application for marketing authorization and could issue an opinion within two months, if the data submitted with the application is sufficiently robust.
The agency’s human medicines committee already reviewed some data on Xevudy during a rolling review. The data came from laboratory and animal studies, and included information on the quality of the drug.
The announcement came a week after the European Medicines Agency recommended the authorization of two other monoclonal antibody treatments — a combination of casirivimab and imdevimab, and the drug regdanvimab. It said both were proven to significantly reduce the risk of hospitalization and death in patients vulnerable to serious COVID-19.


UN’s top court opens Myanmar Rohingya genocide case

Updated 14 min 8 sec ago
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UN’s top court opens Myanmar Rohingya genocide case

  • The Gambia filed a case against Myanmar at the UN’s top court in 2019
  • Verdict expected to impact Israel’s genocide case over war on Gaza

DHAKA: The International Court of Justice on Monday opened a landmark case accusing Myanmar of genocide against its mostly Muslim Rohingya minority.

The Gambia filed a case against Myanmar at the UN’s top court in 2019, two years after a military offensive forced hundreds of thousands of Rohingya from their homes into neighboring Bangladesh.

The hearings will last three weeks and conclude on Jan. 29.

“The ICJ must secure justice for the persecuted Rohingya. This process should not take much longer, as we all know that justice delayed is justice denied,” said Asma Begum, who has been living in the Kutupalong refugee camp in Bangladesh’s Cox’s Bazar district since 2017.

A mostly Muslim ethnic minority, the Rohingya have lived for centuries in Myanmar’s western Rakhine state but were stripped of their citizenship in the 1980s and have faced systemic persecution ever since.

In 2017 alone, some 750,000 of them fled military atrocities and crossed to Bangladesh, in what the UN has called a textbook case of ethnic cleansing by Myanmar.

Today, about 1.3 million Rohingya shelter in 33 camps in Cox’s Bazar, turning the coastal district into the world’s largest refugee settlement.

“We experienced horrific acts such as arson, killings and rape in 2017, and fled to Bangladesh,” Begum told Arab News.

“I believe the ICJ verdict will pave the way for our repatriation to our homeland. The world should not forget us.”

A UN fact-finding mission has concluded that the Myanmar 2017 offensive included “genocidal acts” — an accusation rejected by Myanmar, which said it was a “clearance operation” against militants.

Now, there is hope for justice and a new future for those who have been displaced for years.

“We also have the right to live with dignity. I want to return to my homeland and live the rest of my life in my ancestral land. My children will reconnect with their roots and be able to build their own future,” said Syed Ahmed, who fled Myanmar in 2017 and has since been raising his four children in the Kutupalong camp.

“Despite the delay, I am optimistic that the perpetrators will be held accountable through the ICJ verdict. It will set a strong precedent for the world.”

The Myanmar trial is the first genocide case in more than a decade to be taken up by the ICJ. The outcome will also impact the genocide case that Israel is facing over its war on Gaza.

“The momentum of this case at the ICJ will send a strong message to all those (places) around the world where crimes against humanity have been committed,” Nur Khan, a Bangladeshi lawyer and human rights activist, told Arab News.

“The ICJ will play a significant role in ensuring justice regarding accusations of genocide in other parts of the world, such as the genocide and crimes against humanity committed by Israel against the people of Gaza.”