紐時賞析／抗新冠潛力新藥 面臨上市困難

Promising New Drug To Fight Coronavirus Faces Market Hurdles

抗新冠潛力新藥面臨上市困難

Over the past year, the United States’ arsenal of COVID-19 treatments has shrunk as new variants of the coronavirus have eroded the potency of drug after drug. Many patients are now left with a single option, Paxlovid. While highly effective, it poses problems for many people who need it because of dangerous interactions with other medications.

過去一年，隨著新冠病毒新變異株一次次削減新冠藥物效力，美國新冠肺炎解藥庫不斷縮減。輝瑞新冠口服藥「倍拉維」成了如今許多患者唯一選項。倍拉維相當有效，但會與其他藥物產生嚴重交互作用，對需要它的許多人來說是一大問題。

But a new class of variant-proof treatments could help restock the country’s armory. Scientists on Wednesday reported in The New England Journal of Medicine that a single injection of a so-called interferon drug slashed by half a COVID patient’s odds of being hospitalized.

但新一類不怕變異的療法有望為美國重新補給解藥庫。科學家在「新英格蘭醫學雜誌」八日刊登的文章中指出，只需注射一劑所謂的干擾素藥物，便能讓新冠患者住院機率大幅降低一半。

The results, demonstrated in a clinical trial of nearly 2,000 patients, rivaled those achieved by Paxlovid. And the interferon shots hold even bigger promise, scientists said. By fortifying the body’s own mechanisms for quashing an invading virus, they can potentially help defend against not only COVID, but also the flu and other viruses with the potential to kindle future pandemics.

這個結果得自於一項近兩千名患者參與的臨床實驗，效果與倍拉維不相上下。科學家指出，干擾素注射的潛力甚至大於倍拉維。藉著強化人體本身抵禦外來病毒的免疫機制，干擾素注射不只能協助對抗新冠肺炎，還能抵禦流感與其他可能在日後導致流行病的其他病毒。

For all of its promise, though, the drug — called pegylated interferon lambda — faces an uncertain road to the commercial market. Regulators at the Food and Drug Administration late last year told the drug’s maker, Eiger Biopharmaceuticals, that they were not prepared to authorize it for emergency use. Eiger executives said part of the problem seemed to be that the clinical trial did not include a U.S. site, but rather only sites in Brazil and Canada, and that it was initiated and run by academic researchers, rather than the company itself.

這款名為「聚乙二醇干擾素λ」的新藥雖然潛力無窮，但在上市之前面臨不確定前景。美國食品藥物管理局監管人員去年底向研發該藥的「艾格生物製藥」表示，管理局尚未準備批准其緊急使用。艾格主管指出，部分問題似乎出在該藥臨床試驗地點都未包括美國，只在巴西與加拿大進行，且臨床試驗是由學術研究人員而非艾格公司主導與進行。

The regulators suggested that only a large clinical trial conducted at least in part in the United States and with more involvement from the company would suffice, Eiger executives said, a scenario that would require several years and considerably more funding. An FDA spokesperson said disclosure laws prevented the agency from commenting.

艾格主管說，監管人員建議，至少要部分在美國境內進行的大規模臨床試驗，且公司參與程度增加，才算合格。這個做法要花許多年，以及更大量的資金。一名美國食品藥物管理局發言人表示，披露法律使其無法發表評論。

Those barriers are indicative of problems that some experts worry are threatening the development of a wide range of next-generation COVID treatments and vaccines — products that may help address the ongoing toll from COVID and also give scientists a head start in preparing for the next pandemic.

這些阻礙指出了某些問題，一些專家擔心這些問題將威脅廣泛的下一代新冠療法與疫苗研發，而這些產品可能有助因應新冠肺炎持續帶來的損害，並為科學家提供先機準備下一次大流行。

As it stands, Eiger executives said they might seek authorization for the interferon shot outside of the United States. China, for example, has been looking for new treatment options.

艾格高層表示，依照目前情形，他們可能會尋求美國以外的干擾素注射授權。例如中國就一直在尋求新的治療方案。

文／Benjamin Mueller　譯／陳曉慈