FDA ap­proves 5 new cost­ly drugs well ahead of PDU­FA dates

Since 21 Oc­to­ber, the FDA has been on a tear in ap­prov­ing five new drugs (all with list prices of more than $100,000 per year) months ahead of when they were ex­pect­ed to be ap­proved.

For in­stance, the FDA signed off on Ver­tex Phar­ma­ceu­ti­cals’ Trikaf­ta (elex­a­caftor/iva­caftor/teza­caftor), a new treat­ment for those with the most com­mon cys­tic fi­bro­sis mu­ta­tion, af­ter on­ly three months of re­view and well ahead of its 19 March 2020 user fee ac­tion date.

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