rejection

Alkermes experimental opioid-based depression therapy ALKS 5461 has been rejected by the FDA, it has emerged, in the adjunctive treatment of major depressive disorder (MDD).

The US agency confirmed the decision in a complete response letter, refusing to approve the drug in its current form. Alkermes has been requested to provide additional data to support its efficacy, and the company, in turn, confirmed that it would meet with the FDA to discuss how these concerns could be rectified.

The FDA has rejected Insys Therapeutics buprenorphine sublingual spray due to concerns about the safety of the Arizona-based company’s opioid painkiller.

The US regulator’s decision has come after the FDA advisory committee voted 18-1 against approval of the treatment. The American company sought approval for the sublingual spray, which uses the active ingredient buprenorphine, for the treatment of moderate to severe acute pain earlier this year. However the FDA has rejected the application due to potential safety concerns.

NICE has published a final appraisal rejecting the expanded use of Roche’s Esbriet (pirfenidone) for the treatment of early idiopathic pulmonary fibrosis (IPF) in the UK.

Roche said the decision leaves patients with no treatment option to slow the progression of the disease until lung function has been lost, leaving the UK as one of the only countries in Europe where patients do not have access to treatment for early IPF.

Biomarin (NASDAQ: BMRN) has announced that it has withdrawn its marketing authorisation application for Duchenne muscular dystrophy drug, Kyndrisa (drisapersen), from the European Medicines Agency (EMA).

The board at Medivation has unanimously rejected the $9.8 billion takeover bid from Sanofi.

They declare that Sanofi’s bid of $52.50 per share “substantially undervalues” the company and is “not in the best interests of the company and its stockholders”.

The release of Teva Pharmaceuticals generic for the anaphylaxis treatment, EpiPen (epinephrine), is now expected to be severely delayed after the FDA rejected its version, flagging “major deficiencies”.

The Israeli-based company had originally planned to bring the auto-injector to market in 2017, but this no longer looks to be the case. EpiPen is used to treat anaphylaxis. It is a boost of adrenaline that helps to remedy a serious allergic reaction that is rapid in onset, and may cause death.

The Breakthrough Breast Cancer charity and England’s drug pricing watchdog NICE have both attacked Roche for not lowering the price of its new breast cancer drug Kadcyla.

The drug has been knocked back by NICE today in its final draft guidance for patients with HER2-positive breast cancer that has spread to other parts of the body, cannot be surgically removed and has stopped responding to first-line treatment.

Fifth NICE rejection for the drug

Roche’s Avastin has been rejected once again for use in breast cancer patients. 

NICE has now issued final guidance saying it does not recommend Avastin (bevacizumab), in combination with Roche’s Xeloda, for the firstline treatment of metastatic breast cancer in people for whom treatment with other chemotherapy options including taxanes or anthracyclines, is not considered appropriate. 

NICE has decided once again not to recommend Roche’s Avastin on the NHS for the first line treatment of metastatic breast cancer.

Roche, which described the final draft guidance as ‘disappointing’, wanted Avastin (bevacizumab) used as a first line treatment in combination with Roche’s own chemotherapy drug Xeloda (capecitabine).

NICE, which is expected to issue final guidance next month if there are no appeals against its decision, acknowledged that treatment with Avastin plus Xeloda could delay cancer from progressing for longer than Xeloda alone.