💊 US FDA approves first gene therapies for sickle cell disease; Congo’s mpox outbreak worries WHO; Long Covid afflicts half of African Covid survivors

#490 | Biologic therapies for asthma; Early warning system for diabetes; Roadmap for zero hunger

Hello, and welcome back to The Kable this fine Monday. Our edition today may have a fair share of disease outbreak updates, and that’s not a bad thing – it means that outbreaks in Africa are finally getting recognised before they begin to affect wealthy nations in Europe and North America.

But first, Gaza. At a special session held yesterday in Geneva, the WHO’s Executive Board adopted a resolution by consensus, a first since October 7, to call for “immediate, sustained and unimpeded passage of humanitarian relief, including the access of medical personnel.” Even as the resolution was adopted, the WHO Director-General recognised that it did not resolve the crisis. Here's what he had to say.

The Democratic Republic of Congo (DRC) has reported over 13,000 mpox cases in 2023; that is over twice as many as were recorded during the last peak in 2020. The WHO is “very worried” about the spread of this severe form of mpox that has already killed nearly 600 people, primarily children, in the country this year. With the disease being reported in almost every province of the DRC, the WHO is working with authorities on a response and risk assessment. It hopes to resolve regulatory hurdles so that the government can procure or accept donations of mpox vaccines, which are currently only available in the country in ongoing clinical studies.

In Zambia, the WHO has been alerted about the anthrax outbreak, with fears that the zoonotic disease may spread to neighbouring Zimbabwe, Botswana, and Mozambique. As of 20 November, 684 suspected human cases and four deaths have been reported across 9 of Zambia’s 10 provinces. There are also reports of domestic livestock and wild animals like hippopotami succumbing to an unknown ailment in surrounding areas. Meanwhile, even Uganda is struggling to contain a severe anthrax outbreak. At least 17 people and 40 cows have died of the disease, and the country has imposed a ban on the sale of beef products as well as restrictions on the movement of cattle.

In Singapore, Covid case numbers have hit a record high for 2023, though they are not as high as during the pandemic. In the week ended 2 December, almost 10,000 more cases were recorded compared to the week prior. The number of people being hospitalised and needing intensive care has also risen.

Meanwhile, the US FDA has approved two long-awaited gene therapies for sickle cell disease in patients 12 years of age and older. One of the therapies is Casgevy by Vertex Pharmaceuticals, while the other is Lyfgenia by bluebird bio. Just three weeks ago, with approval from UK regulators, Casgevy had become the first CRISPR-based therapy to be approved anywhere in the world. The FDA has said that patients who receive either of the therapies will be followed in long-term studies; this is particularly important in the wake of recent investigations concerning the development of secondary cancers after treatment with cell and gene therapies. Further, Lyfgenia also comes with a black-box warning that notes that cases of blood cancer have occurred in patients who received the therapy. If that wasn’t enough information to take in about these treatments, wait till you see their price tags – Casgevy will be priced at $2.2 million, while Lyfgenia will be priced at $3.1 million.

The Cipla subsidiary InvaGen Pharmaceuticals, USA, is voluntarily recalling one lot of medication in the US due to seal integrity issues. The medication, Vigabatrin for Oral Solution, is used to treat refractory complex partial seizures in patients two years of age and older. As such, the population at risk is primarily infants and young children, but no adverse events related to the recall have been reported yet.

The US FDA has issued a warning letter to India’s Intas Pharmaceuticals for significant manufacturing lapses, including violations of cGMP regulation, at its Ahmedabad plant.

And finally, amid an outbreak of the deadly African swine fever (ASF) in animals at a licensed farm, Hong Kong authorities have ordered the culling of over 900 pigs. Though often fatal to pigs, ASF does not affect humans.