Pfizer’s rare disease drug, Sanofi’s dengue vaccine bag FDA nod; Lundbeck buys Abide

By PharmaCompass

2019-05-09

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Sanofi’s controversial dengue vaccine — Dengvaxia, which took two decades to develop, has bagged the approval of the US Food and Drug Administration (FDA), albeit with a raft of caveats.

Last week, the US regulator sanctioned the use of Dengvaxia as the first-ever product to prevent the mosquito-borne disease in individuals who have previously contracted dengue and who live in areas rife with the disease. Originally, Sanofi had sought approval for people aged 9 to 45. But the FDA has only recommended its use in individuals aged 9 to 16 who have had laboratory-confirmed previous dengue infection and live in areas where the disease is endemic, such as Puerto Rico, the US Virgin Islands and American Samoa.

The FDA said Dengvaxia — which is administered as three separate injections — was found to be roughly 76 percent effective in preventing symptomatic dengue disease in individuals aged 9 to 16 who previously had laboratory-confirmed dengue disease. However, according to Sanofi, the FDA hasn’t cleared any tests in the United States to determine a previous dengue infection.

Meanwhile, the US FDA has approved Pfizer Inc’s oral drug, tafamidis to treat a rare and fatal heart disease, known as transthyretin amyloid cardiomyopathy.

Tafamidis had earlier been rejected by the FDA. But now, it is ready to disrupt a rare-disease field only recently tapped by Alnylam and Ionis. Pfizer’s tafamidis, to be sold under brand name Vyndaqel, comes at a list price of US$ 225,000 a year for the medicine. According to analysts, its annual sales are forecast to exceed US$ 1 billion in 2024.

Tafamidis is the first approved medicine for the disease in the United States. Pfizer believes there are about 100,000 people in the United States with the condition, the vast majority undiagnosed. Only about 2,000 to 5,000 patients are currently diagnosed with the progressive heart disease globally. The company has been in talks with insurers and is confident the drug will be reimbursed at the US$ 225,000 list price, he said.

Lundbeck buys into cannabinoid platform: New Lundbeck CEO Deborah Dunsire is turning to M&As to build the company’s drug pipeline. Dunsire had agreed to pay US$ 250 million cash to buy San Diego-based Abide Therapeutics, where researchers have been working on a cannabinoid platform for new drugs to treat brain diseases.

In addition to the cash, Lundbeck is keeping aside up to US$ 150 million for milestones. And the drugmaker will be retaining the San Diego base, designating it as a discovery center for Lundbeck.

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