3 Pharma Companies Receive Positive EU Opinions

Pfizer Inc. PFE, Amgen, Inc. AMGN and Eli Lilly and Co LLY received favorable opinions from the European Medicines Agency in response to their respective applications.

Pfizer's IBRANCE®

Pfizer disclosed that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending its IBRANCE® (palbociclib) for marketing authorization. The drug candidate is for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer.

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Amgen's Parsabiv™

Amgen also disclosed that EMA's CHMP adopted a positive opinion for the Marketing Authorization of Parsabiv™ (etelcalcetide). The company indicated that the committee recommended approval for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

The company's EVP of R&D, Sean Harper, said, "Secondary hyperparathyroidism is a disease that affects many patients with advanced chronic kidney disease, and we look forward to continuing to work with regulatory authorities to provide these patients with a novel therapy and advance the management of this complex disease."

Eli Lilly's Olaratumab

The third company in the list of EMA's CHMP is Eli Lilly. The drug maker said that the committee issued a favorable opinion for its Olaratumab and recommended granting of a conditional marketing authorization for the treatment of adults with advanced soft tissue sarcoma (STS) not amenable to curative treatment.

The company claimed that this was the first regulatory step toward approval for Olaratumab.

At Time Of Writing ...

• Amgen was down 0.5 percent at $171.77.
• Eli Lilly was down 0.49 percent at $78.42.
• Pfizer was down 0.32 percent at $34.03.

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