Therapeutic areas in focus
Controversial ALS drug approved by FDA
Although scientists and independent medical experts questioned the drug’s efficacy, the FDA has approved a new drug called Relyviro to treat patients with amyotrophic lateral sclerosis (ALS). The drug has been shown to slow symptoms and extend life, albeit only by a few months.
Most patients with ALS die within three to five years and multiple trials for various ALS drugs and treatments have failed in recent years, so the development and approval of a drug that can extend life by even a few months can only be a positive step for those suffering from ALS.
Initially, the advisory panel recommended that the FDA reject the drug, arguing that Amylyx hadn’t made a convincing case for the efficacy of the drug. However, after pleas from patients and their families, the FDA reconvened the panel this month. More data and further analyses were presented, suggesting that the drug will allow patients with ALS to live for up to 11 months longer than previously expected.
Only two drugs treating ALS have been approved since 1995, and neither is particularly effective, so this controversial approval is a significant step in the treatment of ALS.
Despite the uncertainty around the drug and the controversy of its approval, patients with ALS are eager to use the drug. Marc Litt, a retired cardiologist who was diagnosed with ALS in 2019, states: “Obviously, I realise any treatment won’t cure me now, but if my quality of life can be stabilised, I could enjoy some time with my grandson with what’s left.”
Calaneet Balas, President and CEO of the ALS Association, responded to the indecision around the approval of the drug, stating: “We cannot allow perfection to stand in the way of real progress towards turning ALS from a fatal disease into a liveable one. The FDA’s own ALS guidance acknowledges that people with ALS are willing to accept greater risk for the possibility of some benefit.”
Merck under official investigation in France
Merck, a science and technology company based in Germany, is under investigation after “possibly issuing misleading information” regarding its product Levothyrox, used for treating thyroid issues.
Merck changed the formula for Levothyrox in 2017, removing lactose to make it easier to handle. However, this change has been linked to side effects such as memory loss, weight gain and palpitations.
The plaintiffs have accused Merck of not providing sufficient information regarding the change in its product.
Merck has said that the proceedings, taking place in Marseille, France, are not concerned with the product’s new formula, and that it is about the way the company provided information when changing from the old formula to the new.
Mario-Pierre Stasi, the lawyer for Merck, said the company would continue to co-operate with authorities on the matter and that full legal proceedings must be allowed to run their course.
In March 2022, the Cour de Cassation ‒ France’s highest court ‒ confirmed a 2020 Lyon appeal court ruling, which ordered Merck to pay €1,000 in compensation to the 3,300 people suffering with thyroid problems in France, after the 2017 change of formula.
FDA announces recall of two blood pressure pills over cancer risk
US-based Aurobindo Pharma USA is set to recall two of its blood pressure pills over a potential cancer risk, as reported by the FDA. The drugs in question are quinapril and hydrochlorothiazide, both of which are often used to treat hypertension.
The drugs contain high levels of nitrosamine, a substance that is harmless in low doses but can increase the risk of cancer when consumed in higher levels.
Trade return management service Qualanex, has said it “will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts.” Its announcement continues that “Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Qualanex.”
This recall comes just a few weeks after the FDA had to recall another blood pressure medication, and a drug that lowers the risk of stroke or severe heart issues, due to a packaging mix-up. The drugs have been described as “pink coloured, scored, round shapes, biconvex, film-coated tablets, debossed with ‘D’ on
the scored side and ‘19’ on the other side.”
The FDA commented: “Patients should contact their doctor or healthcare provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication.”