2013年8月6日訊 /生物谷BIOON/ --今年上半年,，美國(guó)FDA僅批準(zhǔn)了13種新型藥物上市，相較于2012年共通過(guò)39項(xiàng)相比,，速度明顯放緩,。這也反映出美國(guó)醫(yī)藥行業(yè)2013年研發(fā)步伐的放緩。而在糖尿病和癌癥領(lǐng)域則勢(shì)頭良好,。
同時(shí),，美國(guó)評(píng)論人士還列出了上半年批準(zhǔn)藥物中前景最好的五種重磅藥物。（生物谷Bioon.com）
詳細(xì)英文報(bào)道：
Few productivity in biopharma measure up to the annual rate of new drug approvals. So now that the FDA has come through with only 13 novel approvals in the first half of the year, well off the pace of 39 new approvals in 2012, there's some handwringing going on.
But it's not as bad as it may appear at first glance.
Back in 2012, the FDA had approved 14 new drugs at the halfway mark, about where we are now. Last year at this point Fitch Ratings was fretting that the pace, behind the 18 new approvals for H1 2011, meant the industry could be headed for a dismal performance. Instead, a strong second half pushed new approvals to 39--the best record in 16 years and a marked improvement on the 32 approvals recorded in 2011.
The new approvals, tabulated by Nature, include Genentech's Kadcyla (T-DM1) for metastatic breast cancer, as well as Biogen Idec's ($BIIB) Tecfidera (BG-12), J&J's ($JNJ) Invokana (canagliflozin) and three drugs for GlaxoSmithKline ($GSK), which needs to rack up some R&D successes after some lean years.
Pfizer's ($PFE) former R&D chief John LaMattina told FirstWord Pharma that the FDA typically does most of its new drug approvals in the second half of the year, and 2013 was still shaping up as a solid year for biopharma on the regulatory front. There's also a wild card to consider this year, with the FDA eager to prove that it means business when it comes to the new breakthrough drug designation, raising the prospect of some early approvals for some key programs.
Earlier this year Fitch was at it again, though, predicting a downturn in new approvals, despite a surge in OKs for cancer and diabetes drugs.
Based on FirstWord's estimates on sales potential, here are the top 5 blockbuster drugs so far this year, as measured in 2018 sales:
Tecfidera (multiple sclerosis): $4.2 billion
Kadcyla (breast cancer): $2.9 billion
Breo Ellipta (COPD): $1.84 billion
Pomalyst (multiple myeloma): $1.28 billion
Nesina (diabetes): $1.1 billion
