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FDA postpones decision for Pfizer's weekly growth hormone treatment

Ascendis continues as the sole once-weekly growth hormone treatment for children with growth hormone deficiency after the US Food and Drug Administration has extended its review period of Pfizer and Opko's competitor drug.

Photo: KENA BETANCUR/AFP / AFP

Pfizer and partner Opko Health must wait patiently before knowing the final fate of its drug candidate somatrogon on the US market, as the US Food and Drug Administration (FDA) has extended the deadline for its review by three months, pushing the final decision into January of next year, Pfizer writes in a press release.

The Danish company Ascendis Pharma can thus continue to reign unchallenged with its drug Skytrofa – perviously Transcon hGH – which for several months will continue to be the only once-weekly treatment for children with growth hormone deficiency (GHD) on the US market. Like Ascendis, Pfizer is aiming for younger patients as the first target group for the growth hormone, which has been in development since 2014 in a collaboration between Pfizer and Opko.

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